Internet Info 1994 March/Internet Info CD-ROM (Walnut Creek) (March 1994).iso/answers/soc/aids-faq/part2

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Section 3.  Confidentiality.

 Q3.1        How is blood tested in the United States?
 Q3.2        What if a blood-bank finds out you are HIV positive?

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Question 3.1.  How is blood tested in the United States?

All blood products in the U.S. are screened by ELISA assays for several
infectious agents, including: HIV 1/2, HTLV I/II, HBV, HCV, Syphillis,
Hepatitis B core, and a liver enzyme ALT, indicative of hepatic
infections.  Some blood donations are also tested for CMV, a more common
virus that has devestating effects in immunocompromised individuals, such
as cancer patients and transplant recipients.

In addition to these laboratories, all donors are screened through
questionaires that meet or exceed FDA requirements.

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Question 3.2.  What if a blood-bank finds out you are HIV positive?

The Red Cross and other blood banks routinely test blood donations for HIV
antibodies.

The Red Cross has specifically asked that people not use blood donation as
a way of finding out if they are HIV+.  If you think you might be
infected, go get a blood test.  Many cities offer free anonymous HIV
testing.  Contact your local public health service office for details.

This is particularly important if you think you might have been infected
within the last six months, since there's the risk that you are indeed
infected, but do not yet have antibodies to HIV.

Blood donation is a fine thing to do--but how will you feel if you donate,
then a month later you find out through some other means that you're HIV+?
We're supposed to be making a gift of life, not death.

The following article discusses how blood banks use the information, if
you have tested positive for HIV antibodies.  In addition to your possible
role in killing another person, donating blood to obtain a free HIV test
also risks your anonymity.

From: McCullough J. The nation's changing blood supply system. JAMA.  1993
May;269(17):2239-45.

"The coded identity of potential or actual blood donors who are found to
be unsuitable on the basis of medical history or laboratory testing is
entered into a donor referral registry (DDR).  Before each donated unit of
blood is made available for use, the coded identity of the donor is
checked against the DDR to ensure that the donor has not been found to be
unsuitable during a previous donation.  Although potentially infectious
donors are so informed and asked not to give blood in the future, this
DDR check is thought to improve the safety of the blood supply by serving
as an additional way of identifying potentially infectious blood should
these donors return.  The American Red Cross operates a single DDR with
information from all of its 47 reginal centers.  However, other blood
banks' DDRs act only locally since there is no requirement that different
blood banks in the same or neighboring communities exchange this DDR
information.  The operation of these DDRs costs money, consumes experts'
time, and has the potential for many abuses such as failure to obtain
informed consent and breeches of confidentiality.  The value of a DDR in
improving the safety of the blood supply has not been established.  An
analysis of the value of thse DDRs should be conducted, and based on the
results, DDRs should be either eliminated or refined into an appropriate
system."

See also: Grossman BJ. Springer KM. Blood donor deferral registries:
highlights of a conference. Transfusion. 1992;32:868-72.

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Section 4.  Treatment options.

 Q4.1        General treatment information.
 Q4.2        AIDS and Opportunistic Infections.
 Q4.3        Guide to Social Security Benefits.
 Q4.4        What if you can't afford AZT?
 Q4.5        What about DNCB? (please contribute)

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Question 4.1.  General treatment information.

[This article was published in AIDSFILE, 1993 Sept, Vol. 7, No. 3, p. 1-3.
(Copyright 1993  The Regents of the University of California).  The
Regents grant permission for material in AIDSFILE to be reprinted for use
by nonprofit educational institutions for scholarly or instructional
purposes only, provided that (1) the author and AIDSFILE are identified;
(2) proper notice of the copyright appears on each copy; (3) copies are
distributed at or below cost.]

     Review of Clinical Guidelines - Antiretroviral Therapy
                     Paul A. Volberding, MD

                          Introduction

     A number of new observations have been made recently concerning
antiretroviral therapy for HIV infection.  Although new data is always
welcome, lately it seems to cause as much confusion as clarification.
Caregivers for patients with HIV disease continue to recognize the
established benefits of antiretroviral therapy, but new uncertainties have
been introduced.  These uncertainties mean that we must consider the new
information in order to make the best use of available treatments at the
same time that we appreciate their limitations.  Those who care for
patients with HIV disease also anticipate the introduction of new classes
of drugs, and we are beginning to determine how we might use these
additional agents in our patient care.

                  Review of Clinical Guidelines

     Antiretroviral therapy clearly has shown activity in delaying the
progression and death of patients with HIV infection, especially when
therapy has been tested in patients with more advanced disease.  But even
in asymptomatic HIV infection there is a general agreement of at least a
transient clinical benefit from the use of nucleoside analog therapy.
It is clear also that antiretroviral therapy improves various laboratory
markers of the disease, including immunologic and virologic disease
markers, such as CD4 cell counts and HIV p24 antigen levels.  Further
evidence of the clinical activity of these drugs comes from trials showing
a second period of benefit when therapy is changed to a
non-cross-resistant agent, for example, switching from zidovudine to ddI.
In addition, we are encouraged by symptomatic improvement in patients with
advanced disease who are started on antiretroviral drugs.  Also, many
retrospective epidemiology studies continue to show a survival advantage
in patients taking these drugs.       Despite continuing agreement on some
of the benefits of antiretroviral therapy, we also face growing
uncertainties.  Recent studies have shown no survival advantage when
antiretroviral drugs are used in asymptomatic HIV infection, and any
benefit in slowing clinical progression seems to disappear when zidovudine
monotherapy, at least, is given for a prolonged period.  Questions
continue as well about the degree of benefit of antiretroviral therapy for
patients with advanced HIV disease.  Early clinical trials of zidovudine,
for example, were done before the routine used of PCP prophylaxis, which,
by itself, delays progression to that common indicator of AIDS.
Questions about the current status of antiretroviral therapy include:
Which drug or combination is superior as initial therapy? When should this
initial therapy begin?  What is the duration of the benefit from initial
therapy?  How long should it be continued before other drugs or
combinations are initiated? Finally it is important to consider: Which
drugs should be used following initial therapy? What might we anticipate
in the future from drugs in current clinical development?

               Beginning Therapy -- What and When

     Probably the easiest question at the moment in the field of HIV
therapy is which drug to use to begin treatment.  Data from ACTG 116A make
it clear that zidovudine is superior to ddI as a monotherapy in previously
untreated patients, and data from other studies show the superiority of
zidovudine over ddC.  An independent "State of the Art Panel" recently
convened by the National Institute of Allergy and Infectious Diseases
(NIAID) and chaired by Merle Sande, MD, UCSF chief of the medical service
at San Francisco General Hospital, found an easy consensus that zidovudine
monotherapy is the initial therapy of choice.       Even here, however,
other opinions may be heard, especially concerning the potential for
initial use of combinations of nucleoside analogs.  For example, the
recent ACTG 155 trial in much more advanced disease tended to show a
superiority of the combination of zidovudine and ddC, which was limited to
patients with the highest CD4 cells (between 150 and 300).  A large study,
ACTG 175, is comparing initial combination with monotherapy, but the
results from this trial are not anticipated before the end of 1995.  In
the meantime, combinations including zidovudine with ddI or zidovudine
with ddC as initial therapy remain of interest.       When best to
initiate antiretroviral therapy is probably the most controversial
question in the field of HIV management.  Extended data from ACTG 019
demonstrate durable clinical progression benefit with the use of 500 mg of
zidovudine daily in patients with asymptomatic HIV infection and with CD4
cell counts between 300 and 500, but these data are in apparent conflict
with those from the recently completed Concorde Study.  Concorde,
enrolling more than 1700 patients with any level of CD4 count, compared
the initial use of one gram of zidovudine daily with the same therapy
deferred until after the person developed AIDS or ARC.       After a
median treatment duration of three years, and despite a clear and
sustained CD4 improvement with the immediate use of zidovudine, there was
no apparent benefit in the immediate treatment group either in clinical
progression or survival.  When the investigators analyzed a subset of the
overall group with CD4 counts below 500 cells and after one year of
therapy, a benefit similar to that seen in ACTG 019 was observed.
Although Concorde was a powerful study, given the size and duration of
follow-up, concerns have been raised that the dosage at one gram was
excessively high and that the large number of patients allowed to begin
therapy before they became symptomatic complicates the analysis.  Also
adding to the confusion are the recently published results of the
European-Australian cooperative Group trial, which tended to find a
clinical benefit with the use of zidovudine in patients with CD4 counts up
to 750 cells.       The State of the Art Panel recommended two broad
options after considering the available data--initiating therapy in
asymptomatic individuals with CD4 counts under 500 cells, or delaying this
therapy until symptomatic HIV disease intervened.  Another option favored
by many clinicians is to follow patients, delaying therapy until evidence
of more rapid disease progression becomes apparent as manifested by rapid
declines in CD4 count or by a rise in p24 antigen or, especially, a rise
in beta-2 microglobulin.  At any rate, the clinician must discuss the
various options with each patient, individualizing this decision according
to the clinical and laboratory status of the patient and according to the
patient's own desires.

Duration of Therapy

     A second difficult question in the field of HIV management is how
long to continue initial zidovudine.  Again, the ACTG 019 experience would
suggest that zidovudine monotherapy has a prolonged period of benefit,
especially in patients with higher CD4 cell counts (300-500) when therapy
is begun.  On the other hand, ACTG 116A seemed to indicate that the
initial superiority of zidovudine was lost after as little as two to four
months of treatment with this drug prior to treatment with didanosine.
Here again, the State of the Art panel could find little room for
consensus.  When therapy is begun in individuals with CD4 counts above
300, the panel suggested that it should be continued until the CD4 cell
count fell below 300.  When zidovudine monotherapy is begun in patients
with CD4 counts under 300, the additional option of switching to ddI
monotherapy after a fixed interval was raised, but again this interval was
not defined.       Once zidovudine monotherapy has been used, and when it
is no longer felt to be effective for an individual, secondary therapy
must be initiated.  The choice of this therapy, however, is also
uncertain.  In moderate disease, with CD4 cell counts below 300, switching
to ddI was superior to continuing with zidovudine in ACTG trials 116a and
116b/117, while switching to ddC was not of benefit in ACTG 155.  On the
other hand, from data gathered in CPCRA Trial 002, in patients with more
advanced disease, ddI and ddC were equivalent in secondary treatment of
patients previously treated with zidovudine who had progressed despite
taking that drug or who were intolerant of zidovudine toxicity.  In fact,
ddC had a slight but significant superiority compared to ddI in terms of
survival in this trial.       It was hoped that combination therapy
following zidovudine would be beneficial but questions have been raised
following the results of ACTG 155.  In this study, patients previously
treated with zidovudine with CD4 cells below 300 were randomized to stay
on zidovudine, start ddC monotherapy, or begin zidovudine and ddC
combination therapy.       Overall, there was no difference in clinical
progression or survival among the three study arms.  When the baseline CD4
counts are examined, however, it was found that combination therapy was
superior in patients with higher CD4 cell counts, especially between 150
and 300.  Therefore, it might seem advisable not to delay the introduction
of combination therapy until patients have very advanced disease but
rather to use such therapy earlier in the disease course.  Whether
zidovudine and ddI would be as good as zidovudine and ddC has not been
investigated.

Newer Classes of Drugs

     Along with new data on existing therapies, more information is
available now on newer classes of drugs.  These include nucleoside
analogs, non-nucleoside reverse transcriptase inhibitors, protease
inhibitors, and the tat inhibitor.

Nucleoside Analogs.  New nucleoside analogs in clinical investigation
include d4T (stavudine) and 3TC.  d4T has been much more extensively
studied and appears effective in raising CD4 count and lowering HIV p24
antigen in a number of Phase 1 trials.  It appears safe.  Although cases
of pancreatitis have been reported, they seem to be extremely rare.
Neuropathy is the main toxicity but, again, it appears to be somewhat less
than with ddI or ddC.  d4T may not be suitable for combination with
zidovudine as the two drugs have a negative interaction limiting their
activation within the cell.  On the other hand, d4T is a well-tolerated
drug and may prove to be an alternative to one or more of the existing
nucleosides.  3TC also appear safe and may be able to help restore
sensitivity to zidovudine when the patient's HIV has become resistant.

Reverse Transcriptase Inhibitors.  The non-nucleoside reverse
transcriptase inhibitors, including nevirapine and the Merck "L" drug,
were recently thought to have limited value because they induce high-level
drug resistance so rapidly.  At the Berlin conference, however, one report
showed that by increasing the dosage of nevirapine to 400 mg daily, a dose
well above the level of resistance, prolonged benefit might be achieved.
Also, it was shown that combining zidovudine with nevirapine delays the
onset of nevirapine resistance.  Thus, these drugs may still find a place
in clinical medicine.       At the same time, convergent therapy, using
three drugs together, was disappointing because of simultaneous resistance
to zidovudine, ddI and non-nucleoside reverse transcriptase inhibitors.

Protease Inhibitors.  Protease inhibitors seem to be gaining some ground.
In Phase 1 trials, several of these compounds have evident antiretroviral
activity, which was reflected in decreasing HIV p24 and increasing CD4
cell counts.  Clinical benefits have not been established nor has the
activity of these drugs used in combination with zidovudine been
described.  Because several structurally different protease inhibitors are
being developed by different drug companies, it is hoped that at least one
of these compounds will become more widely available soon for clinical
use.  Tat.  While the protease inhibitors appear encouraging, tat
inhibitors appear to be clinically inactive.  In Phase 1 trials of the
Hoffman LaRoche tat inhibitor, little or no antiretroviral activity was
seen and it is probably that this class of drugs will not be developed
further.

Summary

     Given this complex and seemingly confusing information, what
recommendations can be given to the clinician?  Most important is to
individualize the decision-making and to consider the desires of the
patient even more than previously.  Some patients gravitate easily to more
aggressive therapy, while others prefer a more conservative therapeutic
approach.  With the former, initiating therapy at or even above 500 CD4
counts, perhaps even with a combination of zidovudine and ddI, may be
considered.  For more conservative patients, however, following the
recommendations of the Concorde study may in order.  In other words, defer
the initiation of zidovudine monotherapy until the onset of clinical
symptoms.       Once the choice of initial therapy has been made, all
other recommendations must also be individualized.  No firm data are
available to guide the decision about how long to continue a therapy or
even about what to use next.  Most of these options have not been compared
directly in clinical trials.  It would seem advisable to continue therapy
longer in patients with relatively earlier disease when therapy is
initiated.  On the other hand, if patients have more advanced disease, for
example, are symptomatic or have CD4 cell counts below 300 when therapy is
begun, then a more rapid alteration of therapy to a non-cross-resistant
drug or combination should be considered.  The goal in each patient is to
continue effective antiretroviral therapy for as long as possible,
discontinuing the therapy if further benefits appear impossible.
Although the results of recent clinical trials are disappointing in some
respects, it nevertheless is important to have these data.  Only then can
we adjust our expectations and our patients' expectations of
antiretroviral treatment and learn how to make the best use of the drugs
that we have available.  Recognizing the increasing need for the
development of new classes of more effective drugs in combinations, we
must still seek to maintain the optimism that enables progress in our
patients' care.

     Dr. Volberding is a UC San Francisco professor of medicine and
Director, UCSF AIDS Program at San Francisco General Hospital.

References: ZDV and The AIDS Clinical Trials Group (1989-93):

Aweeka FT.  Gambertoglio JG.  et al.  Pharmacokinetics of concomitantly
administered foscarnet and zidovudine for treatment of human
immunodeficiency virus infection (AIDS Clinical Trials Group protocol
053).  Antimicrobial Agents & Chemotherapy.  36(8):1773-8, 1992 Aug.

Fischl MA.  Richman DD.  et al.  The safety and efficacy of zidovudine
(AZT) in the treatment of subjects with mildly symptomatic human
immunodeficiency virus type 1 (HIV) infection.  A double-blind,
placebo-controlled trial. The AIDS Clinical Trials Group [see comments].
Annals of Internal Medicine.  112(10):727-37, 1990 May 15. [Editor's Note:
This article reports the results of ACTG 106.]

Fischl MA.  Parker CB.  et al. A randomized controlled trial of a reduced
daily dose of zidovudine in patients with the acquired immunodeficiency
syndrome. The AIDS Clinical Trials Group.  New England Journal of
Medicine.  323(15): 1009-14, 1990 Oct 11.

Gelber RD.  Lenderking WR.  et al.  Quality-of-life evaluation in a
clinical trial of zidovudine therapy in patients with mildly symptomatic
HIV infection. The AIDS Clinical Trials Group.  Annals of Internal
Medicine.  116(12 Pt 1):961-6, 1992 Jun 15.

Hochster H.  Dieterich D.  et al.  Toxicity of combined ganciclovir and
zidovudine for cytomegalovirus disease associated with AIDS.  An AIDS
Clinical Trials Group Study.  Annals of Internal Medicine.  113(2):111-7,
1990 Jul 15.

Kahn JO.  Lagakos SW.  et al.  A controlled trial comparing continued
zidovudine with didanosine in human immunodeficiency virus infection. The
NIAID AIDS Clinical Trials Group [see comments].  New England Journal of
Medicine. 327(9):581-7, 1992 Aug 27.

Koch MA.  Volberding PA.  et al.  Toxic effects of zidovudine in
asymptomatic human immunodeficiency virus-infected individuals with CD4+
cell counts of 0.50 x 10(9)/L or less. Detailed and updated results from
protocol 019 of the AIDS Clinical Trials Group.  Archives of Internal
Medicine.  152(11):2286-92, 1992 Nov.

Krogstad DJ.  Eveland MR.  et al.  Drug level monitoring in a double-blind
multicenter trial: false-positive zidovudine measurements in AIDS clinical
trials group protocol 019.  Antimicrobial Agents & Chemotherapy.  35(6):
1160-4, 1991 Jun.

Meng TC.  Fischl MA.  Richman DD.  AIDS Clinical Trials Group: phase I/II
study of combination 2',3'-dideoxycytidine and zidovudine in patients with
acquired immunodeficiency syndrome (AIDS) and advanced AIDS-related
complex.  American Journal of Medicine.  88(5B):27S-30S, 1990 May 21.

Sidtis JJ.  Gatsonis C.  et al.  Zidovudine treatment of the AIDS dementia
complex: results of a placebo-controlled trial. AIDS Clinical Trials
Group.  Annals of Neurology.  33(4):343-9, 1993 Apr.

Sperling RS.  Stratton P.  Treatment options for human immunodeficiency
virus-infected pregnant women. Obstetric- Gynecologic Working Group of the
AIDS Clinical Trials Group of the National Institute of Allergy and
Infectious Diseases.  Obstetrics & Gynecology.  79(3):443-8, 1992 Mar.

Volberding PA.  Lagakos SW.  et al.  Zidovudine in asymptomatic human
immunodeficiency virus infection. A controlled trial in persons with fewer
than 500 CD4-positive cells per cubic millimeter. The AIDS Clinical Trials
Group of the National Institute of Allergy and Infectious Diseases [see
comments].  New England Journal of Medicine.  322(14):941-9, 1990 Apr 5.
[Editor's Note: This article reports the results of ACTG 109.]

See also:

Aboulker JP.  Swart AM.  Preliminary analysis of the Concorde trial.
Concorde Coordinating Committee [letter].  Lancet.  1993 Apr
3;341(8849):889-90.  Comment in: Lancet 1993 Apr 17;341(8851): 1022-3;
Lancet 1993 Apr 17;341(8851):1023; Lancet 1993 May 15; 341(8855):1276;
Lancet 1993 May 15;341 (8855):1276-7; and Lancet 1993 May
15;341(8855):1277.

Cooper DA. Gatell M. et al.  Zidovudine in persons with asymptomatic HIV
infection and CD4+ cell counts greater than 400 per cubic millimeter.  New
England Journal of Medicine.  329(5): 297-303, 1993 Jul 29.

Hamilton JD.  Hartigan PM.  et al.  A controlled trial of early versus
late treatment with zidovudine in symptomatic human immunodeficiency virus
infection.  Results of the Veterans Affairs Cooperative Study.  New
England Journal of Medicine.  326(7):437- 43, 1992 Feb 13.

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Question 4.2.  AIDS and Opportunistic Infections.

AIDS and Opportunistic Infections

NIAID BACKGROUNDER: Office of Communications, National Institute of
Allergy and Infectious Diseases, National Institutes of Health, Bethesda,
Maryland  20892 - September 1993

Opportunistic infections (OIs) cause most of the illnesses and deaths
among people infected with HIV, the virus that causes AIDS.  The National
Institute of Allergy and Infectious Diseases (NIAID) leads the way in U.S.
research on these life-threatening infections.  As part of the NIAID
effort, investigators are defining the optimal therapies, alone and in
combination, to prevent and treat OIs.  They seek ways to identify
infections earlier and recognize resistance to therapies more quickly.

What are OIs?

The immune systems of most people with HIV gradually deteriorate, leaving
them vulnerable to numerous viruses, fungi, bacteria and protozoa that are
held in check in people with healthy immune systems.  These microbes can
become active in HIV-infected individuals, causing frequent and severe
disease.

NIAID uses a two-pronged approach to the prevention and treatment of OIs:
basic laboratory research to learn how these microbes cause disease and
clinical research to develop and evaluate promising therapies.

Prevention and treatment of one such disease, Pneumocystis carinii
pneumonia or PCP, has been a major thrust of the NIAID program.  Other
NIAID investigations include cytomegalovirus (CMV) infection,
Mycobacterium avium complex (MAC) and tuberculosis (TB).  Institute
research focuses on these infections because, although they occur
repeatedly among HIV-infected people, they are rare in the general
population and few drugs are available now to prevent and treat them.

PCP:  The Most Common OI

PCP remains the most common, life-threatening opportunistic infection in
people with HIV, occurring in up to 80 percent of individuals who do not
take preventive therapy.

The PCP organism, a microscopic parasite, appears to infect most people
during childhood. In people with healthy immune systems, the parasite
normally remains dormant, but it may cause disease in those with damaged
immune systems.

PCP infection is characterized by a dry cough and shortness of breath.
Individuals may experience other, less specific symptoms such as fever,
fatigue and weight loss for weeks or even months before respiratory
problems appear.  As PCP infection progresses, the functioning lung tissue
becomes clogged, which decreases the transport of oxygen from the inhaled
air into the blood.  At this point, the oxygen in the blood may be lowered
to dangerous or even fatal levels.

Without treatment, close to 100 percent of HIV-infected patients with PCP
die.  During the 1980s, the development of effective therapies led to
better management of PCP. Drugs for preventing and treating PCP include
aerosolized pentamidine and oral trimethoprim-sulfamethoxazole (TMP/SMX),
but both can result in serious side effects that prevent some patients
from taking the drugs.

TMP/SMX is recommended more often than aerosolized pentamidine for
treating and preventing PCP because the combination is effective,
tolerated by about half of the patients who take it and may work against
other disease-causing organisms as well.  In 1992, an NIAID-supported
trial proved that TMP/SMX is better than aerosolized pentamidine at
preventing a second episode of PCP in people with AIDS who can tolerate
either therapy.

Although definitive research data are lacking, other agents may be
considered in situations in which neither TMP/SMX nor aerosolized
pentamidine can be given.  The drug atovaquone is approved for patients
with mild to moderate PCP who cannot tolerate TMP/SMX.  One NIAID study
showed that primaquine, an antimalaria drug, with clindamycin is an
effective oral therapy for PCP.  TMP with dapsone is an alternative
treatment.

The search for new, more effective, less toxic drugs and combinations of
drugs to fight PCP continues.  NIAID studies play an important role in
this effort.  One trial compares three drug regimens--TMP/dapsone,
primaquine/clindamycin and TMP/SMX--for oral treatment of mild to moderate
PCP.  Another protocol looks at an 8-aminoquinoline, an antimalaria drug,
while a third trial considers two regimens of TMP/SMX to prevent PCP.

CMV:  A Herpesvirus

Infection with CMV, a virus in the herpes family, may occur throughout
life.  By age 50, about half of the general population has been exposed to
this virus, yet most people do not become ill.  After the original
infection, the virus may lie dormant and reactivate itself if the immune
system becomes suppressed.

For people with HIV infection, CMV is one of the most frequent and serious
OIs they face.  CMV retinitis, an inflammation of the light-sensitive
inner layer of the eye, is the most common CMV infection and leads to
blindness if left untreated.  Infections also may occur in the
gastrointestinal tract, lungs, brain, heart and other organs.

Both intravenous ganciclovir and foscarnet are approved to treat CMV
retinitis.  Lifelong maintenance on either treatment is required because
the drugs do not kill CMV, they merely slow down its ability to grow.
Even with therapy, the rate of relapse is high.

NIAID studies of CMV and other herpesviruses have shown that intravenous
foscarnet and ganciclovir are equally effective for CMV retinitis,
although foscarnet was associated with increased survival for patients in
the study.  An ongoing trial is testing an oral form of ganciclovir to
prevent CMV disease.  The oral form of the drug would be much easier and
safer for patients to take.

MAC:  A Bacterial OI

Infection with MAC is diagnosed in up to 40 percent of people with AIDS in
the United States, making it the most common bacterial OI.  Usually, it
affects people in advanced stages of HIV disease when the immune system is
severely suppressed.

The MAC organism is found widely in the environment and is thought to be
acquired most commonly through the mouth or gastrointestinal tract.  It
can spread to the lungs, liver, spleen, lymph nodes, bone marrow,
intestines and blood.  MAC causes chronic debilitating symptoms--fever,
night sweats, weight loss, fatigue, chronic diarrhea, abdominal pain,
liver dysfunction and severe anemia.

Rifabutin is the first drug to be approved for preventing MAC disease in
people with advanced HIV infection.  The Food and Drug administration
based this approval on clinical studies showing that patients who received
rifabutin were one-third to one-half as likely to develop MAC as were
patients who received placebo.

To prevent MAC disease, a U.S. Public Health Service Task Force on
Prophylaxis and Therapy for MAC suggests that patients with HIV infection
and fewer than 100 CD4 + T cells receive oral rifabutin for the rest of
their lives unless disease develops.  In the latter case, multiple drug
treatment is needed.  CD4+ T cells are immune system cells targeted and
killed by HIV.  No other drug regimen is recommended currently to prevent
MAC. Azithromycin and clarithromycin are promising agents for prophylaxis,
but studies of these agents have not been completed.

Increasing evidence suggests that treatment can benefit patients with
disseminated MAC, especially multiple-drug regimens including either
clarithromycin or azithromycin.  Therefore, the PHS task force suggests
that all regimens, outside of a clinical trial, should consist of at least
two drugs, including clarithromycin or azithromycin plus one other agent
such as clofazimine, rifabutin, rifampin, ciprofloxacin and, in certain
situations, amikacin.  They recommend continued therapy for the patient's
lifetime, as long as clinical benefit and reduction of mycobacteria are
observed.

NIAID has several studies under way looking at the roles of clarithromycin
and azithromycin, and other drugs such as sparfloxacin, alone and in
combination, to prevent and treat this serious disease.

TB:  An Airborne Disease

TB, a chronic bacterial infection, causes more deaths worldwide than any
other infectious disease.  About one-third of the world's population
harbors the predominant TB organism, Mycobacterium tuberculosis, and is at
risk for developing the disease.      The World Health Organization (WHO)
estimates that 4.4 million people worldwide are coinfected with TB and
HIV.  WHO predicts that by the year 2000, TB will take one million lives
annually among the HIV-infected.

Because of their weakened immune systems, people with HIV are vulnerable
to reactivation of latent TB infections, as well as to new TB infections.
Transmission of this disease occurs most commonly in crowded environments
such as hospitals, prisons and shelters--where HIV-infected individuals
make up a growing proportion of the population.

Active TB may occur early in the course of HIV infection, often months or
years before other OIs.  TB most often affects the lungs, but it also can
cause disease in other parts of the body, particularly in people with
advanced HIV disease.

Of particular concern for people with AIDS is multi-drug-resistant TB
(MDR-TB).  MDR-TB can occur when patients fail to take their TB medicine
for the prolonged periods necessary to destroy all TB organisms, which
then become resistant to the drugs.  These resistant organisms can be
spread to other people.  Even with treatment, for individuals coinfected
with HIV and MDR-TB, the death rate may be as high as 80 percent, as
opposed to 40 to 60 percent for people with MDR-TB alone.  The time from
diagnosis to death may be only months for some patients with HIV and
MDR-TB, as they are sometimes left without adequate treatment options.

The initial site of TB infection is in the balloon-like sacs at the ends
of the small air passages in the lungs.  In these sacs, white blood cells
called macrophages ingest the inhaled TB organism.  Some of the organisms
are killed immediately, while others remain and multiply within the
macrophages.  If the organism breaks out of the sacs, TB can become active
disease.  This spreading sometimes results in life-threatening meningitis
and other problems.

NIAID launched the first large U.S. study to assess TB treatment
strategies for people coinfected with HIV and TB.  The study is aimed at
finding state-of-the-art treatment.  NIAID is the lead institute for TB
research at the National Institutes of Health, supporting more than 50
research projects related to TB.

Other OIs

NIAID-supported scientists also study other OIs including fungal
infections, herpes simplex virus infections, toxoplasmosis and
cryptosporidium infections.

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Question 4.3.  Guide to Social Security Benefits.

U.S. Department of Health and Human Services
Social Security Administration
SSA Publication No. 05-10020
September 1993

          A Guide to Social Security and SSI Disability
             Benefits For People With HIV Infection

About This Booklet

Social Security can provide a lifeline of support to people with HIV
infection.  That lifeline comes in the form of monthly Social Security
disability benefits and Supplemental Security Income payments, Medicare
and Medicaid coverage, and a variety of other services available to people
who receive disability benefits from Social Security.

If you are disabled because of HIV infection, this booklet will help you
understand the kinds of disability or Supplemental Security Income
programs.

What's Inside

Part 1 -- Background Information The first section provides some brief
background information about HIV infection and Social Security.

Part 2 -- What Benefits Are You Eligible For? This section explains the
nonmedical rules and eligibility factors for Social Security Disability
Insurance benefits and Supplemental Security Income Disability payments.

Part 3 -- How Does Social Security Define "Disability?" This section
explains Social Security's definition of "disability" and how it relates
to claimants with HIV infection.

Part 4 -- How Does Social Security Evaluate Your Disability This section
explains how Social Security evaluates disability claims involving HIV
diseases in general.  And it includes up-to- date information about the
way we process claims, especially those involving women and children with
HIV infection.

Part 5 -- How Do You File For Disability Benefits? This section includes
information about when and how to apply for disability, what steps we take
to ensure that your claim is processed quickly and accurately, and most
important, what things you can do to help the process along.  Also
included is information about situations when we can presume a person is
disabled and make immediate payments.

Part 6 -- Helping You Return To Work This section provides an overview of
special rules designed to help you return to work.

Part 7 -- What you Need To Know About Medicaid And Medicare This section
includes a brief overview of the kinds of benefits available from the
Medicaid and Medicare programs.

For More Information

***************************************************************** PART 1
-- BACKGROUND INFORMATION

Acquired immunodeficiency syndrome (AIDS) is characterized by the
inability of the body's natural immunity to fight infection.  It is caused
by a retrovirus known as human immunodeficiency virus, or HIV.  Generally
speaking, people with HIV infection fall into two broad categories:

     1) those with symptomatic HIV infection, including AIDS; and      2)
those with HIV infection but no symptoms.

     Although thousands of people with HIV infection are receiving Social
Security or Supplemental Security Income disability benefits, we believe
there may be others who might be eligible for these benefits.  Social
Security is committed to helping all men, women, and children with HIV
infection learn more about the disability programs we administer.  And if
you qualify for benefits, we are just as committed to ensuring that you
receive them as soon as possible.       You should also be aware that the
Social Security Administrations's criteria for evaluating HIV infection
are not linked to the Centers for Disease Control's (CDC) definition of
AIDS.  This is because the goals of the two agencies are different.  CDC
defines AIDS primarily for surveillance purposes, not for the evaluation
of disability.

PART 2 -- WHAT BENEFITS ARE YOU ELIGIBLE FOR?

We pay disability benefits under two programs: Social Security Disability
Insurance, sometimes referred to as SSDI, and Supplemental Security
Income, often called SSI.  The medical requirements are the same for both
programs, and your disability is determined by the same process.  However,
there are major differences in the nonmedical factors, which are explained
in the next two sections.

Social Security Disability Insurance Benefits: The Nonmedical Rules Of
Eligibility

Here are examples of how people qualify for SSDI:

o    Most people qualify for Social Security disability by working,
paying Social Security taxes, and in turn, earning "credits"      toward
eventual benefits.  The maximum number of credits you      can earn each
year is 4.  The number of credits you need to      qualify for disability
depends on your age when you become      disabled.  Nobody needs more than
40 credits and young people      can qualify with as few as 6 credits.

o    Disabled widows and widowers age 50 or older could be eligible
for a disability benefit on the Social Security record of a      deceased
spouse.

o    Disabled children age 18 or older could be eligible for
dependent's benefits on the Social Security record of a parent      who is
getting retirement or disability benefits, or on the      record of a
parent who has died. (The disability must have      started before age
22.)

o    Children under the age of 18 qualify for dependents benefits      on
the record of a parent who is getting retirement or      disability
benefits, or on the record of a parent who has      died, merely because
they are under age 18.

     For more information about Social Security disability benefits in
general, ask Social Security for a copy of the booklet, Disability
(Publication No. 05-10029).

How Much Will Your Benefits Be?

How much your Social Security benefit will be depends on your earnings
history.  Generally, higher earnings translate into higher Social Security
benefits.  You can find out how much you will get by contacting Social
Security and asking for an estimate of your benefits.  We'll give you a
form you can use to send for a free statement that contains a record of
your earnings and an estimate of your benefits.       In addition to
checking your benefit, we encourage you to use this statement to verify
that your earnings have been properly recorded in our files.  It's
important that you do this because any missing or unreported wages could
lower your Social Security benefit or even prevent you from qualifying for
disability benefits.  If you find a problem, contact your local Social
Security office right away, show them proof of your actual wages, and the
record will be corrected.  This can be particularly important for people
who have tested positive for HIV but have not developed symptoms, so that
any potential benefits will not be delayed by wage correction efforts.
Disabled widows, widowers, and children eligible for benefits as a
dependent on a spouse's or parent's Social Security record receive an
amount that is a percentage of the worker's Social Security benefit.

Supplemental Security Income: The Nonmedical Rules Of Eligibility

SSI is a program that pays monthly benefits to people with low incomes and
limited assets who are 65 or older, or blind, or disabled.       As its
name implies, "Supplemental" Security Income "supplements" a person's
income up to a certain level that can go up every year based on
cost-of-living adjustments.  The level varies from one state to another,
so check with your local Social Security office to find out more about SSI
benefit levels in your state.       We don't count all the income you have
when we figure out if you qualify for SSI.  And if you work, there are
special rules we use for counting your wages.  Again, check with Social
Security to find out if you can get SSI.       In addition to rules about
income, people on SSI must have limited assets.  Generally, individuals
with assets under $2000, or couples with assets under $3000, can qualify
for SSI.  However, when we figure your assets, we don't count such items
as your home, your car (unless it's an expensive one), and most of your
personal belongings.       Your Social Security office can tell you more
about the income and asset limits.  For more general information, ask for
a copy of the booklet, SSI (Publication No. 05-11000).

PART 3 -- HOW DOES SOCIAL SECURITY DEFINE DISABILITY?

In this section, we'll explain the criteria you must meet in order to be
considered "disabled." First, we'll explain in general terms how Social
Security defines and determines disability.  Then we'll discuss how it
applies to people with HIV infection.

The General Definition Of Disability

Disability under Social Security is based on your inability to work
because of a medical condition.  You will be considered disabled if you
are unable to do any kind of "substantial" work for which you are suited.
(Usually, monthly earnings of $500 or more are considered substantial.)
Your ability to work must be expected to last at least a year.  Or, the
condition that keeps you from working must be so severe that you are not
expected to live.       For children, we decide how the condition affects
their ability to function--to do the things and behave in the ways that
other children of the same age normally would.

How This Definition Of Disability Applies To People With HIV Infection

A person with symptomatic HIV infection is often severely limited in his
or her ability to work.  In other words, if the evidence shows that you
have symptomatic HIV infection that severely limits your ability to work,
and if you meet the other eligibility factors, the chances are very good
that you will be able to receive Social Security or SSI Benefits.       On
the other hand, some people with HIV infection may be less impaired and
able to work, so they may not be eligible for disability.

PART 4 -- HOW DOES SOCIAL SECURITY EVALUATE YOUR DISABILITY?

Social Security works with an agency in each state, usually called a
Disability Determination Service (DDS), to evaluate disability claims.  At
the DDS, a disability evaluation specialist and a doctor follow a
step-by-step process that applies to all disability claims, thus assuring
a consistent approach to evaluating disability.       First, the DDS
specialists decide whether your impairment is "severe."  This simply means
the evidence must show that your disability interferes with your ability
to work.       The next step in the process is deciding whether the
disability is included in a list of impairments.  This list describes, for
each of the major body systems, impairments that are considered severe
enough to prevent an adult from doing any substantial work or in the case
of children under the age of 18, impairments that are severe enough to
prevent a child from functioning in a manner similar to other children of
the same age.       Recently we published a list of impairments for HIV
infections.  In this list, we have included many conditions associated
with symptomatic HIV infection, including some that specifically apply to
women and children with HIV infection (See next two sections).       Some
of the HIV-related conditions included in the HIV list of impairments are
shown below.  The level of severity that an impairment must meet to be
found disabling are also specified in the regulations.

o  Pulmonary tuberculosis resistant to treatment

o  Kaposi's sarcoma

o  Pneumocystis carinii pneumonia (PCP)

o  Carcinoma of the cervix

o  Herpes Simplex

o  Hodgkin's disease and all lymphomas

o  HIV Wasting Syndrome

o  Syphilis and Neurosyphilis

o  Candidiasis

o  Histoplasmosis

     Remember: these are just a few examples.  You can see a complete list
of HIV-related impairments at any Social Security office.  The complete
list will also include the findings necessary for listed impairments to be
considered disabling by Social Security.       If you have symptoms of HIV
infection that are not specifically included in (or equal in severity to)
the impairments on our list, then DDS disability specialists will look at
how frequently these conditions occur and how they affect your ability to
function.       The DDS team will evaluate how well you function in three
general areas:  daily activities; social functioning; and the ability to
complete tasks in a timely manner, which requires the ability to maintain
concentration, persistence, and pace.       If you have "marked
limitations" in any one of these functional areas and repeated
manifestations of HIV meeting the criteria in the listings, you may be
found disabled.  A marked limitation is one that seriously interferes with
your ability to function independently, appropriately, and effectively.
It does not mean that you must be confined to bed, hospitalized, or in a
nursing home.  If the specialists decide that you are not disabled at this
point because you do not have a condition that exactly matches or is equal
in severity to one on our list, then they will look to see if your
condition prevents you from doing the work you normally do.  If it does
not, then we look to see if it prevents you from doing any other type of
work you're suited for, based on your age, education, and experience.  If
it does, you may still be found disabled.       Remember, at all steps in
the process, your impairment must be documented.  Documentation includes
medical records from your doctors, as well as laboratory test results,
X-ray reports, etc.  The HIV infection itself--that is, the presence of
the virus--must be documented as well as any HIV-related manifestations.
At all steps in the process it is important that we have evidence of
signs, symptoms, and laboratory findings associated with HIV infection, as
well as information on how well you are able to function day-to-day.  The
signs and symptoms may include: repeated infections; fevers/night sweats;
enlarged lymph nodes, liver or spleen; lower energy or generalized
weakness; dyspnea on exertion; persistent cough; depression/anxiety;
headache; anorexia; nausea and vomiting; and side effects of medication
and/or treatment, as well as how your treatment affects your daily
activities.

Evaluation Of HIV Infection In Women

Statistics show that there is an increasing number of women with HIV
diseases.  Social Security's guidelines for the immune system recognize
that HIV infection can show up differently in women than in men.  In
addition to following the criteria outlined in the previous section, DDS
disability evaluators consider specific criteria for diseases common in
women.  These include: vulvovaginal candidiasis (yeast infection); genital
herpes; pelvic inflammatory disease (PDI); invasive cervical cancer;
genital ulcerative disease; and condyloma (genital warts caused by the
human papillomavirus).  Again, the level of severity necessary for these
impairments to be considered disabling is included in the list of
impairments.

Evaluation Of HIV Infection In Children

We also have separate listings for children with HIV infection.  These
guidelines recognize the fact that the course of the disease in children
can differ from adults.  As with adults, some children may not appear to
have the conditions specified in the guidelines, or may have listed
conditions that are not as severe as the guidelines require.  When this
happens, a functional assessment is made using criteria contained in the
lists.  A child may be disabled if the HIV-related impairments
substantially reduce his/her ability to grow, develop, or engage in
activities similar to children of the same age.       For more information
about disability benefits for children, ask Social Security for a copy of
the booklet, Social Security And SSI Benefits For Children With
Disabilities (Publication No. 05- 10026).

PART 5 -- HOW DO YOU FILE FOR DISABILITY BENEFITS

You apply for Social Security and SSI disability benefits by calling or
visiting any Social Security office.  All Social Security files are kept
strictly confidential.  It would help if you have certain documents with
you when you apply.  But don't delay filing because you don't have all the
information you need.  We'll help you get the rest of it after you sign
up.  The information you'll need may include:

o  your Social Security number and birth certificate;

o  the Social Security numbers and birth certificates for family members
signing up on your record; and

o  a copy of your most recent W-2 form (or your tax return if you're
self-employed).

     If you're signing up for SSI, you will need to provide records that
show that your income and assets are below the SSI limits.  This might
include such things as bank statements, rent receipts, care registration,
etc.

You'll also need to give us information about how your condition affects
your daily activities, the names and addresses of your doctors and clinics
where you've received treatment, and a summary of the kind of work you've
done in the last 15 years.  If you have medical evidence such as reports
of blood tests, laboratory work, or a physical, it would be helpful if you
brought them with you.  In the section below (What You Can Do to Expedite
the Processing of Your Claim), we give you some guidelines for providing
us with medical and vocational information that will help speed up your
claim.  But first, we want you to know what Social Security does to make
the process work as smoothly as possible.

What Steps Has Social Security Taken To Ensure Prompt Processing And
Payment Of Disability Benefits?

All HIV infection claims are given prompt attention and priority handling.
For many people applying for SSI with a medical diagnosis of symptomatic
HIV infection, the law allows us to PRESUME they are disabled.  This
permits us to pay up to 6 months of benefits pending a final decision on
the claim.  You will qualify for this immediate payment if:

o  a medical source confirms that the HIV infection is severe enough to
meet SSA's criteria;

o  you meet the other SSI nonmedical eligibility requirements; and

o  you are not doing "substantial" work (See section, "The General
Definition of Disability" in Part 3).

     If you have symptomatic HIV infection but the local Social Security
office cannot provide immediate payment, a disability evaluation
specialist at the DDS may still make a "presumptive" disability decision
at any point in the process where the evidence suggests a high likelihood
that your claim will be approved.  (If we later decide you are not
disabled, you will NOT have to pay back the money you received.)

     Special arrangements have been made with a number of AIDS service
organizations, advocacy groups, and medical facilities to help us get the
evidence we need to streamline the claims process.  And many DDS's have
Medical/Professional Relations Officers who work directly with these
organizations to make this process work smoothly.

What You Can Do To Expedite The Processing Of Your Claim

You can play an active and important role in ensuring that your claim is
processed accurately and quickly.  The best advice we can give you is to
keep thorough records that document the symptoms of your illness and how
it affects your daily activities, and then to provide all of this
information to Social Security when you file your claim.  Below are some
guidelines you can follow:

o  Document the symptoms of your illness early and often

Use a calendar to jot down brief notes about how you feel on each day.
Record any of your usual activities you could not do on any given day.  Be
specific.  And don't forget to include any psychological or mental
problems.

o  Help your doctor help you

Not all doctors may be aware of all the kinds of information we need to
document your disability.  Ask your doctor or other health care
professional to track the course of your symptoms in detail over time and
to keep a thorough record of any evidence of fatigue, depression,
forgetfulness, dizziness, and other hard-to-document symptoms.

o  Keep records of how your illness affected you on the job

If you were working, but lost your job because of your illness, make notes
that describe what it is about your condition that forced you to stop
working.

o  Give us copies of all these records when you file

In addition to these records, be sure to list the names, addresses, and
phone numbers of all the doctors, clinics, and hospitals you have been to
since your illness began.  Include your patient or treatment
identification number if you know it.  Also include the names, addresses,
and phone numbers of any other people who have information about your
illness.

PART 6 -- HELPING YOU RETURN TO WORK

If you return to work, Social Security has a number of special rules,
called "work incentives," that provide cash benefits and continued
Medicare or Medicaid coverage while you work.  They are particularly
important to people with HIV disease who, because of the recurrent nature
of HIV-related illnesses, may be able to return to work following periods
o disability.

     The rules are different for Social Security and SSI beneficiaries.
For people getting Social Security disability benefits, they include a
9-month "trial work period" during which earnings, no matter how much,
will not affect benefit payments; and a 3-year guarantee that, if benefits
have stopped because a person remains employed after the trial work
period, a Social Security check will be paid for any month earnings are
below the "substantial" level (generally $500).  In addition, Medicare
coverage extends through the 3-year timeframe after the trial work period,
even if your earnings are substantial.

     SSI work incentives include continuation of Medicaid coverage even if
earnings are too high for SSI payments to be made, help with setting up a
"plan to achieve self-support" (PASS), and special consideration for pay
received in a sheltered workshop so that SSI benefits may continue even
though the earnings might normally prevent payments.

     These and other work incentives are explained in detail in the
publication, Working While Disabled...How Social Security Can Help
(Publication No. 05-10095).  For a free copy, just call or visit your
nearest Social Security office.

PART 7 -- WHAT YOU NEED TO KNOW ABOUT MEDICAID AND MEDICARE

Medicaid and Medicare are our country's two major government-run health
insurance programs.  Generally, people on SSI and other people with low
incomes qualify for Medicaid, while Medicare coverage is earned by working
in jobs covered by Social Security, for a railroad, or for the federal
government.  Many people qualify for both Medicare and Medicaid.

Medicaid Coverage

In most states, Social Security's decision that you are eligible for SSI
also makes you eligible for Medicaid coverage.  (Check with your local
Social Security or Medicaid office to verify the requirements in your
state.)

     State Medicaid programs are required to cover certain services,
including inpatient and outpatient hospital care and physician services.
States have the option to include other services, such as intermediate
care, hospice care, private duty nursing, and prescribed drugs.

     For more information about Medicaid, contact your local Medicaid
agency.

Medicare Coverage

If you get Social Security disability, you will qualify for Medicare
coverage 24 months after the month you became entitled to those benefits.
Medicare helps pay for:

o  inpatient and outpatient hospital care;

o  doctor's services;

o  diagnostic tests;

o  skilled nursing care;

o  home health visits;

o  hospice care; and

o  other medical services.

     For more information about Medicare, call or visit your local Social
Security office to ask for the booklet Medicare (Publication No.
05-10043).

FOR MORE INFORMATION

For more information or to apply for benefits, call or visit Social
Security.  It's easiest to call Social Security's toll-free telephone
number.  The number is 1-800-772-1213.  You can speak to a representative
7 a.m. to 7 p.m. each business day.  The best times to call are early in
the morning, early in the evening, late in the week, and toward the end of
the month.

     The Social Security Administration treats all calls
confidentially--whether they're made to our toll-free numbers or to one of
our local offices.  We also want to ensure that you receive accurate and
courteous service.  That's why we have a second Social Security
representative monitor some incoming and outgoing telephone calls.

Note from the AIDS Information Center:  This document reflects changes in
Social Security rules that took effect on July 2, 1993 and, also, how SSA
evaluates claims based on HIV/AIDS.  Copies of this publication, available
in English and Spanish, can be ordered through Social Security's toll-free
number, 1-800-772-1213.  The publication numbers are 05-10020 (English)
and 05-10920 (Spanish).  For bulk quantities call the Public Information
Distribution Center at [phone].  The fax number for ordering
publications is [phone].

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Question 4.4.  What if you can't afford AZT?

        PATIENT ASSISTANCE PROGRAM AT BURROUGHS WELLCOME

     The Burroughs Wellcome Company has announced changes in its Patient
Assistance Program (PAP) to make access to its drugs easier for
disadvantaged patients.  Physicians can now call a toll-free number, once
they have determined that a patient is in need, to receive authorization
to enroll the patient in the program.  Upon authorization, the physician
will give the patient a prescription benefit card from PCS Health Systems
that can be used at any pharmacy.

     To qualify, patients must meet the following guidelines:

o  be a resident of the United States or its territories;

o  be financially disadvantaged;

o  have applied for and be awaiting reply from other prescription funding
sources; or

o  not qualify for private or government assistance.

     The primary patient groups expected to participate are those using
Burroughs Wellcome products for HIV and related infections, those with
herpesvirus infections, transplant recipients, and those with cancer or
congestive heart failure.

     Enrollment in the PAP must be initiated by a physician.  To find out
if an individual is eligible, patients should have their physicians call
[phone].

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Question 4.5.  What about DNCB? (please contribute)

  (please contribute to this FAQ)