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AIDS TREATMENT NEWS Issue #205, August 19, 1994
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS

Human Growth Hormone Reverses Wasting in Clinical Trial

Yokohama Conference Overview

BARRON'S: "Do We Have Too Many Drugs for AIDS?"

Major FDA Public Meeting on Early Access, Accelerated
Approval, Sept. 12-13

Nutrition and AIDS: Interview with Kristin Weaver (Part 2)


***** Human Growth Hormone Reverses Wasting in Clinical Trial

by John S. James

A multicenter placebo-controlled trial with 178 volunteers
has shown clear evidence that human growth hormone can
reverse wasting syndrome, which causes many deaths in cases
of advanced AIDS. It is the first treatment for wasting which
has been proven to consistently restore lean body mass,
according to principal investigator Morris Schambelan, M.D.,
an endocrinologist at San Francisco General Hospital. The
data was analyzed immediately before the Yokohama conference
and first reported at that meeting. The results were not
surprising, because there have been positive anecdotal
reports from patients and physicians involved in the trial.

To be eligible for the Serono study, patients had to have
lost at least 10 percent of their pre-illness weight, or to
weigh less than 90 percent of their ideal body weight; those
in the trial had lost an average of 14 percent. Since the
hormone could not work if people did not eat, study
volunteers had to be able to eat at least 75 percent of their
estimated caloric requirement. Exercise may also be helpful,
but the study did not prescribe it, due to the difficulty of
designing an exercise program suitable for a scientific
study; participants were not discouraged from exercising,
however.

In the trial, 90 volunteers received growth hormone (an
average dose of 6 mg per day -- 0.1 mg per kilogram --
administered subcutaneously each day) and 88 received placebo
for three months; after that time, all were given "open
label" access to the drug, and some have been on it for up to
two years, providing additional information about long-term
safety.

During the trial, patients in the placebo group initially
gained an average of one pound, but lost most of this again
during the three months. Those in the growth-hormone group
gained an average of more than three and a half pounds, and
have sustained or increased this gain afterwards; several
patients eventually gained more than 20 pounds while on
extended treatment.

More interesting was an average gain in lean body mass of
more than six pounds during the trial. Since this is more
than the weight gain, it means that participants lost an
average of about three pounds of fat. In this study, lean
body mass was measured by a high-tech system called DEXA
(dual energy X-ray absorptiometry), which is generally used
for measurement of bone density, but has been adapted for
measurement of body composition. However, a much simpler
system known as bioelectrical impedance has been shown to be
comparable to DEXA.

There were five deaths among the 178 volunteers during or
shortly after the three-month trial; three were receiving the
hormone and two were on placebo. These deaths were due to
infections in persons with very low T-helper counts. (The
average T-helper count of the persons in the trial was 84,
with half of them being below 50.)

Human Growth Hormone -- Background

Human growth hormone is a prescription drug which has been
approved in the U.S. for several years for treating growth-
hormone deficiency in children; it is currently sold by
Genentech Inc. (trade name Protropin) and by Eli Lilly and
Company (trade name Humatrope). The recent trial, however,
was sponsored by a different company, Serono Laboratories
Inc., which has its own human growth hormone which is now
approved in 50 countries but not in the U.S., due to
exclusivity provisions of the Orphan Drug Act; that
exclusivity ran out in March 1994, and the company is now
seeking FDA approval for treating children with growth-
hormone deficiency, in addition to investigating the drug's
efficacy in the wasting syndrome.

There are slight biological differences between the versions
of human growth hormone sold by the different companies, with
the Serono product being derived from mammalian cells, and
the others from bacteria. There is no evidence that the
products act differently in people, however.

When used to treat wasting syndrome, human growth hormone
seems to work by a direct effect on protein metabolism, not
necessarily by correcting a growth-hormone deficiency.

Since human growth hormone can cause various side effects, it
must be used cautiously.

Unfortunately, human growth hormone is very expensive.
Increasing competition may reduce the price somewhat, but it
will still remain an expensive drug. With the new study,
there is now a strong case for its medical necessity in some
AIDS patients; this should make reimbursement easier. (An
earlier study was published in 1993 (1); this should
strengthen the case for reimbursement.)

Serono is now sponsoring another large controlled trial, with
180 patients, one third of whom are receiving placebo. This
trial will focus on additional safety data, to satisfy the
FDA. Once the product is approved specifically for AIDS
wasting, reimbursement should be automatic.

Nutrition for HIV-Associated Wasting -- Brochure Available

Serono Laboratories is producing an educational brochure of
nutrition information for persons with wasting syndrome; it
is useful regardless of whether human growth hormone or any
other treatment is used. The text appeared in the June 1994
issue of BETA (Bulletin of Experimental Treatments for AIDS)
published by the San Francisco AIDS Foundation. For a free
copy, call Gina Cella at Serono, 800/283-8088 ext. 5251, or
write to her attention at: Serono Laboratories, Inc., 100
Longwater Circle, Norwell, MA 02061.

References

1. Mulligan K, Grunfeld C, Hellerstein MK, Neese RA, and
Schambelan M. Anabolic effects of recombinant human growth
hormone in patients with wasting associated with human
immunodeficiency virus infection. JOURNAL OF CLINICAL
ENDOCRINOLOGY AND METABOLISM. 1993; volume 77, number 4,
pages 956-962.


***** Yokohama Conference Overview

by John S. James

The Tenth International Conference on AIDS, August 7-12 in
Yokohama, Japan, generated the usual media gloom about the
lack of effective treatments. The gloom is understandable;
AIDS treatment development has been a disaster (despite all
the attention to the one major success of the last year, the
two-thirds reduction of transmission of HIV from pregnant
women to their babies by use of AZT). But the press did not
report the intense interest behind the scenes, the fact that
this conference may have marked the release of more useful
scientific advance than any other.

For example, research into long-term survivors, and other
studies of the pathogenesis of HIV disease, started being
taken seriously about two or three years ago, and the results
are now coming in. It is now widely suspected that there are
some people who are infected with HIV but who may never
progress to AIDS or other illness. And careful laboratory
studies of ten long-term nonprogressors, reported by David D.
Ho, M.D., of the Aaron Diamond AIDS Research Center, found
that the T-helper cells of these people had no special
resistance to HIV infection, and yet the level of virus in
their blood was extremely low. What seemed to be protective
was a very strong immune response, mainly due to their CD8
cells, and also due to neutralizing antibodies. (Other
researchers have found that some CD8 cells produce a soluble
substance, which has not yet been identified, which prevents
the growth of HIV; it is now known that this substance works
as an inhibitor of the LTR, the long terminal repeat, of the
virus.) Also, the virus in those nonprogressors often
appeared to be defective or attenuated. While information
like this does not immediately provide a new treatment, it
provides guideposts for understanding what needs to be done
to control HIV infection, why the current drugs are not doing
so, and what might be needed in drugs which would work
better. This does not, of course, give people something they
can use today.

HIV RNA Tests

What we believe is the most important development that people
can use now -- although it is still experimental, and just
beginning to come into clinical practice -- is measuring
viral load or viral activity by testing for HIV RNA, either
by quantitative PCR or by the branched DNA (bDNA) assay.
These tests, which tell how much virus is circulating in the
blood plasma, were discussed in detail in our last issue
(AIDS TREATMENT NEWS #204, August 5, 1994), which was
published before the conference; and we went to Yokohama
primarily to learn more about this development. We were
surprised by the breadth and depth of research interest, with
RNA testing coming up in session after session, and much new
data reported. The strong consensus of the researchers is
that the level of virus in blood plasma can be tested
accurately and consistently with the RNA tests, and that this
measurement probably does provide useful information about
how well treatments are working, although this is unproven
until more research is done. Some are concerned about RNA
tests coming into routine use in clinical practice at this
time, before more is known about how to use them, but it is
widely recognized that increased clinical use is imminent.

Why do we believe that this is important? One reason is when
a person is about to start a new antiviral drug, or make a
change in their ongoing antiviral treatment (such as a
different dose, or a different combination therapy), it is
now possible to get a good idea, within about a month, of how
well the new treatment is working for them. They need to get
a baseline test before making the change, and then get the
test again a few weeks later, to see if the level of virus in
the blood has gone down, and by how much. (The RNA level can
change very rapidly, even in a few days, so it is necessary
to get the baseline test before starting the new treatment,
in order to test that treatment correctly; it is not good
enough to be tested shortly after starting.)

If the new treatment is not an antiviral, but some other kind
of treatment for HIV disease such as an immune-based therapy,
then the HIV RNA test might still be useful, as a measure of
whether the treatment is helping the body to control the
virus. But much less is known about how to interpret the test
results in this case; we will have to learn, either from
clinical trials or from clinical experience, what can be
expected from various treatments, and how long it may take
for the level of virus in the blood to change.

Also, note that RNA measurements can be used in the same way
to test a "mainstream" treatment (such as AZT or ddI), or an
"alternative" treatment (such as herbal or other substances
that may have anti-HIV activity). As a result, there is now
more reason to be interested in alternative treatments than
there used to be. This is because the biggest problem with
many alternative treatments was that there was no way to ever
find out if they were working -- since there would never be
enough money or other resources to run a clinical trial
powerful enough to see if the treatment helped the "average"
patient. Now it is possible to watch the effect in an
individual person; and if the effect is striking enough, and
is seen often enough, then the resources will be mobilized to
run a formal trial and get a general answer. As a result, the
hundreds of unproven treatments that people do use will now,
for the first time, have a chance to prove themselves; the
best are likely to come to light and move forward into
trials. The resulting contribution to better AIDS treatment
could be incalculable.

Practical Treatments

There were few practical treatments reported in Yokohama
which were not already known before the meeting. But the
results of a trial of human growth hormone as a treatment for
wasting syndrome became available to the researchers only in
recent weeks, and were reported in Yokohama for the first
time. We interviewed the presenter afterwards, and summarized
the results in an article which appears in this issue. There
have been other trials of human growth hormone for wasting
syndrome, but this one is by far the largest and best
designed.

There were many other reports which were suggestive of new
treatment possibilities, or which may have immediate
practical use for physicians and patients. We are still
reading the conference materials and contacting experts for
additional information, which we will present in future
issues.



***** BARRON'S: "Do We Have Too Many Drugs for AIDS?"

by John S. James

The August 15 issue of BARRON'S (the Dow Jones business and
financial weekly) has a cover article, "Do We Have Too Many
Drugs for AIDS?" The cover includes the following summary:
"In a turnabout, some AIDS activists are now asking the
government to slow down its drug-approval process. What it
means for pharmaceutical companies."

Inside the paper, the article is titled "Rushing to
Judgment." Its main points are that the FDA's accelerated-
approval process for speeding the approval of drugs for AIDS,
cancer, and other serious and life-threatening diseases has
not worked, and that AIDS activists are calling for the FDA
to go back to requiring placebo trials -- even if they take
thousands of patients and require many years for drug
approval.

This article addresses a subject which has become bitterly
controversial among AIDS activists. But it only presents one
side. Some widespread concerns are:

* The article is likely to damage AIDS, cancer, and other
research by making it less attractive to investors, if they
think that accelerated approval is about to be abandoned, and
that activists are likely to oppose approval of their drugs
by the FDA.

* Much of the article concerns AIDS treatment activists --
which carries the piece journalistically, as otherwise there
would certainly not be a cover article, and probably not an
article at all. Yet there is not a shred of evidence that the
reporter talked to any AIDS activist outside of a single
organization -- the Treatment Action Group (TAG), located in
New York, which has taken positions strongly opposed by other
treatment activists and people with HIV. The article mentions
TAG, but does not identify the only two activists it
interviewed as TAG members. And it devotes less than half a
sentence to acknowledging that other views exist.

But we have found little support for and much opposition to
the "activist" view described in the BARRON'S article, that
the FDA should delay approving new AIDS drugs in the name of
better data. Instead, once safety and activity of a drug have
been shown, people want the freedom to make their own
choices. But most patients and physicians have not heard that
the controversy exists, and have no idea what is being
advocated in their behalf.

* In discussing placebos, the article states, "While commonly
used in many other drug trials, placebos have been an
anathema in tests of AIDS drugs, in large part because AIDS
activists have vehemently protested against them." In fact,
placebos are commonly used in AIDS trials, with little or no
protest; for example, a placebo was used in the human growth
hormone trial reported in this issue, and while we know two
volunteers in that trial, and activists who have protested
other aspects of the study, we have not heard any controversy
about the placebo.

The real controversy is not about placebos, but about trials
designed to find statistically significant differences
between two or more treatments in the number of deaths or
major illnesses, often euphemistically called "clinical
endpoints." These trials present special ethical issues
(whether or not they use a placebo), because those who design
and conduct them know very well that unless they get quite a
number of these "endpoints," enough for statistical proof,
the whole trial will have been a waste. In theory, the
accepted standard of ethics demands that such a trial not be
run unless it really is not known which treatment arm is
best. But in practice, investors are unlikely to pay for the
trial unless they have reason for confidence about the
outcome.

Placebos are not an issue if the trial is designed to catch
people and get them into appropriate care before serious
damage is done. But how can one reconcile this approach to
patient care with a trial which is designed to record serious
damage and count the bodies?

Clinical Trial Design

How, then, will we ever test drugs and know for sure what
works, what keeps people alive longer? Our full answer to
that question would not fit into this short article. But the
first step is to realize that comparing the time to death or
deterioration implies that one is testing marginal
treatments. And these tests take several years, meaning that
we must wait several years for the definitive answers about
drugs already known to be marginal several years ago. Do we
really want to structure much of AIDS drug development around
getting good data, years late, on bad drugs?

The alternative is to realize that nobody can predict in
advance what is going to work. Therefore, we need to design
drug development systems so that hundreds of potential
treatments and approaches have a chance to begin to prove
themselves and build credibility, bit by bit, if they are
able to; eventually the best of these could progress into
formal trials of various kinds. But until now, the barriers
to any movement by new treatments and new ideas have been so
high that few can move at all without major corporate
support. Very few of them will have such support in the
beginning; and if it is true that no one can know in advance
what will work, then it follows that the drugs which do get
corporate support are not really the best prospects, but are
essentially selected at random. And the rest remain stuck
forever.

The new blood tests for viral RNA will allow some treatment
ideas to begin to move. Drugs which are already in human use,
or which can easily be used in clinical practice, will now be
able to begin developing credibility, if they merit it. We
should work with technological change to design more
flexible, individualized drug development, instead of
imposing rigid doctrines to address the problems of the past.

Consensus Statement Circulated -- How to Sign On

Project Inform is circulating a two-page "Consensus Statement
on Accelerated Approval, August 5, 1994." It supports the
current system of accelerated approval for early access to
new AIDS treatments, against proposals to make the system
more restrictive. Project Inform is seeking sign-on by
organizations, and most importantly by HIV physicians.
Current signers include the Community Consortium (which
represents most of the HIV physicians in San Francisco), ACT
UP/New York's Treatment and Data Committee, Project Inform,
AIDS TREATMENT NEWS, BETA, SEARCH Alliance, and Mobilization
Against AIDS.

Project Inform can fax or mail you a copy; call them at
415/558-8669.

Project Inform is also encouraging individuals and
organizations who want to support early access and
accelerated approval to write to Commissioner David Kessler,
mail code HF-1, U.S. Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857.


***** Major FDA Public Meeting on Early Access, Accelerated
      Approval, September 12-13

A two-day public meeting of the FDA Antiviral Advisory
Committee is shaping up as one of the important AIDS policy
and community meetings of the year. It is important to let
the FDA and the pharmaceutical industry know that the AIDS
community insists on early access to new treatments, and
strongly supports accelerated approval. The meeting location
is not set as we go to press, but it will be in the
Washington D.C. area.

The following is from a fax we received from the FDA on
August 17; we have edited it slightly for clarity:

"The meeting is the 12th and 13th of September. Since there
are going to be three other meetings within a month on
surrogate markers, we are going to focus more on early access
and accelerated approval at the two-day meeting. It will also
be different in format, with much more time for public
comment, and several times scheduled for comments. There will
be a fax mailing announcing details soon through the AIDS
coordination office.

"In brief, the meeting will start with a history of making
drugs available early for life-threatening conditions, in
particular looking at the oncology experience. We will review
parallel track and treatment INDs as they have been used in
HIV drugs. There will be a point on the agenda here for
comments on access issues, standards for widespread use, and
the effects of widespread use on clinical trials and drug
approval. Hopefully both the community and industry will
share their perspectives. I think since d4T was approved that
this is the first time in many years that there hasn't been
an active parallel track or treatment-IND program in effect.

"Second, the meeting will look at the historical examples of
the use of accelerated approval: ddI (accelerated approval in
practice, although not in name), ddC/AZT, clarithromycin for
MAC treatment, and d4T. We will look at the evidence
available at the time of approvals, the pace of confirmatory
trials, what we have learned from each of these examples.

"Third, we will look for specific proposals to improve the
process of early access and accelerated approval. This would
be a time, for example, when TAG or anyone else who would
like to present the LST [large simple trial], or any other
proposal, could put it on the table. There have also been
some suggestions about bringing accelerated approval drug
candidates to the Advisory Committee early in their
development to get consensus on a reasonable portfolio of
trials, and proposals to strengthen the confirmatory trial
requirement process. I am sure there are others.

"The Advisory Committee will not be asked to formally vote on
any specific issue. The emphasis instead will be on open and
wide-ranging comments on how to best use these tools in the
future (including dealing with products still under
accelerated approval). We will try to develop a document with
points for a sponsor to consider when developing a drug that
is a candidate for early access.

"Anyone wishing to speak for longer than 5-10 minutes should
send us a request, including the topic, so we can arrange an
agenda. There will be time for comments not scheduled, but
they will need to be brief. Requests to speak can be sent
through Lee Zwanziger, FDA, CDER, HFD-9, 5600 Fishers Lane,
room 8B-45, Rockville, MD 20857."

Note: Persons who want to send a written statement to the
Antiviral Advisory Committee should also send it to Lee
Zwanziger at the above address. She is the executive
secretary of the Committee.

Note: The three other meetings on surrogate markers [such as
HIV RNA tests], mentioned above, include:

(1) "Surrogate Markers of HIV: Strategies and Issues for
Selection and Use," October 12-14, at the Sheraton National
Hotel in Alexandria, Virginia. The organizer is Cambridge
Healthtech Institute, Waltham, Massachusetts, 617/487-7989,
or fax [phone]. The press is invited.

(2) "FDA Accelerated Approval: Dealing with Uncertainty,"
Friday, September 23, at the American Academy of Arts and
Sciences, near Harvard Square in Cambridge, Massachusetts.
This meeting is sponsored by the Tufts Center for the Study
of Drug Development, ML Strategies, Inc., Project Inform, and
Gay Men's Health Crisis. The organizer is ML Strategies,
Inc., Boston, Massachusetts, 617/542-6000. We could not reach
the person in charge before going to press.

We could not find out about the third meeting by press time.


***** Nutrition and AIDS: Interview with Kristin Weaver
      (Part 2)

by Tadd Tobias and John S. James

[Note: This is the continuation of the interview with Kristin
Weaver, R.N., M.S.N., C.N.S.N., of the Bay Area Nutrition
Counseling Center and Clinic (BANC) at San Francisco General
Hospital. Part I appeared in our last issue, #204; copies are
available from AIDS TREATMENT NEWS, 800/TREAT-1-2. Note the
resource list at the end of the interview.]

Nutritional Supplements

ATN: What about nutritional supplements like Ensure?

KW: People should be working with a dietitian or physician
who really knows these products and knows which will be
appropriate for each individual, because they can be
expensive (about $20 a six pack for some kinds). Ensure is a
good supplement but may not be appropriate for someone with
fat malabsorption (often present in HIV disease). Because of
its high percentage of fat, Ensure can exacerbate the
diarrhea. Advera is fairly new, with fish oil and medium-
chain triglycerides. It has a different kind of protein, a
peptide, that is easily digested. Other supplements include,
but are not limited to, Vivonex, Nutren, Peptamen, etc.

In general, you might want to look at supplements which have
a large percentage of medium-chain triglycerides (MCTs),
which are a form of fat that is readily absorbed. We did a
study for fat-malabsorbing diarrhea using a product with a
high percentage of MCTs. The diarrhea decreased by at least
half its original amount following the use of the MCT product
and a low fat diet.

ATN: Which product?

KW: Lipisorb. Nutren is also excellent, and perhaps more
tasty. I say this because our nutritionists routinely involve
us in taste tests of all liquid supplements; if we're going
to recommend supplements for our patients, we need to know
how they taste, too.

ATN: What about fluids? Are there increased needs in HIV
disease?

KW: If a person is having fevers or diarrhea, they're going
to be losing a lot of fluid. It's very important that you
replace electrolytes [as well as the water]. People can die
from electrolyte imbalance -- sodium, potassium, chloride
especially. The infant formula Pedialite is one option, but
it is expensive and heavy to carry. We were recommending
Gatorade, because that does have electrolyte replacement, but
it can be expensive if you're drinking a lot, and it has
sugar which could exacerbate the diarrhea. People say, why
not just drink water? But that will wash out even more of the
acid and electrolytes in the stomach, leading to further
metabolic imbalances.

A while ago our pharmacy obtained oral rehydration salts from
the World Health Organization. The formula is pretty bland;
you can taste a little salt. I believe it would be good to
add that to the water, then dilute your nectars or other
juices you may be drinking to replace your electrolytes. It
comes in little packets for about 50 cents. Hopefully we'll
see people using more of this.

[Note: For information on how to obtain rehydration salts,
see the resource section at the end of this interview.]

Food Advice; Deficiencies

ATN: Any general dietary advice?

KW: Eat a more healthy diet -- including, for example,
skinless chicken, and a variety of fresh fruits and
vegetables. You need meat and other sources of protein. We do
not advocate very restricted diets because it's hard to get
the full protein, carbohydrate, fat, vitamins and so on that
you need, with alternative diet therapy. It's difficult to
say generically, "Eat more healthily," because you have to
consider a person's individual lifestyle, how much money they
have, where they're living, do they have a significant other
who can shop and cook for them -- any number of things need
to be considered.

ATN: What about vitamin and mineral deficiencies?

KW: Several micronutrient deficiencies have been identified
in HIV disease: B-6, B-12, zinc, copper, selenium, thiamin
and folate. Deficiencies may be because of intestinal damage
from infections or illnesses; vitamin B-12 especially may not
be absorbed. Selenium deficiencies may lead to
cardiomyopathy. Zinc deficiency may contribute to anorexia
and diarrhea, as well as altered immunity; conversely, zinc
excess can further contribute to immune dysregulation.

A study by Dr. Beach looked at people with some cognitive
deficiencies and found that they were deficient in B-6 and B-
12 in particular. When they supplemented these back up to a
normal level, the dysfunction cleared up. There are many
possible reasons why a person's cognitive function is "not
quite right" -- general malnutrition or even micronutrient
deficiency might be the cause. However -- you don't want to
automatically tell someone to take extra B-6 and B-12,
without documenting serum levels of these vitamins.

ATN: What about toxicities from overdoses of certain
vitamins, especially fat-soluble vitamins (A, D, E, K)?

KW: Fat-soluble vitamins not immediately needed by the body
are stored in the liver. When probably over 60 percent of HIV
patients have some form of liver disorder, and they are
storing fat-soluble vitamins on top of that, it may
exacerbate some liver-related problems. Other toxicities
could be causing diarrhea, such as high-dose vitamin C or
zinc, etc. Anemia, hair loss -- these could be caused by
deficiencies, but they could also be caused by toxic levels
of various micronutrients.

Excessive amounts of vitamin C [can cause] a nutrient
imbalance; particularly if taken with large doses of zinc,
this can lead to copper depletion, which can further
contribute to immune dysregulation. Unless people are
familiar with these interactions it is important to get help
from a qualified registered dietitian or physician to make
educated decisions.

We recommend, as part of an individualized therapy plan, to
take one multivitamin a day. Often we recommend prenatal
vitamins [because they include low or moderate doses of all
the known vitamins, etc. that you need, whereas other
multivitamins usually have some missing].

Some articles in the literature report taking 20 to 200 times
the RDA of certain vitamins, etc. might be beneficial. More
work needs to be done in this area; I would not recommend
that you can take these treatments without concern. And in
addition to the issues already discussed, taking megadoses
can be expensive, and limited funds may be spent on
supplements rather than on quality food. Whatever water-
soluble vitamins your body can't use are flushed out through
the kidneys... in other words, you end up with every
expensive urine and little benefit from the megadosing.

ATN: With HIV disease the body experiences hypermetabolism,
which may cause nutrient needs to be different than the U.S.
RDA. What guidance can you give people who can't access a
dietitian? Is there something you can refer them to that
explains these interactions?

KW: That's a good question. The ADA Consumer Nutrition
Hotline is available to you. (See below.)

People can "guestimate" what their metabolic needs are for 24
hours with the following: calories: multiply 30-35 calories
times your weight in kilograms; for protein needs, multiply
1.5 to 2.0 grams of protein times your weight in kilograms.
These amounts will most likely help to maintain weight during
relatively non-stressful times. If an opportunistic infection
occurs, the body's needs may rise by 60%. Fever will raise
the body's metabolism 7% for each degree Fahrenheit above
normal. A registered dietitian can calculate your body's
needs using an equation that takes into account your age,
sex, height, and weight. This method also considers factors
such as degree of illness and level of activity.

Other Topics

ATN: What about special "alternative" diets?

KW: Some alternative therapy diets work for some people, but
they may not have enough protein, carbohydrate, and fat. And
they can be dangerous; for example, there's one that
encourages you to eat moldy food to see if you're really
sensitive to it. This could be even more detrimental to
somebody who is immune compromised.

ATN: What about Chinese herbal remedies, teas, etc.

KW: I think there is something to a history of thousands of
years of herbology -- and there are certainly conditions that
western medicine cannot do a thing about, yet there may be
some relief from non-traditional therapies. I do believe that
HIV disease would benefit from a combination of eastern and
western medicine.

The concern I have is that people will go into a sports
nutrition shop or health food store and buy whatever is
recommended to them. People may spend a great deal of their
money on supplements rather than quality foods. Here is where
it is vitally important that people align themselves with a
medical professional who can advise them on what to take.

ATN: And antioxidants?

KW: It's too early to have definitive answers. Antioxidants
occur in foods. If you are already taking a multivitamin, you
will be getting some that way, also. Examples of antioxidants
are vitamins C and E, beta carotene, zinc, selenium.
Antioxidants are said to neutralize free radicals in the body
that contribute to immune dysfunction, aging, heart disease,
and cancer.

ATN: In choosing a multivitamin, what potency (dose) should
you look for?

KW: If your multivitamins are a bit more potent than the RDA,
that won't hurt, as long as you are only taking one a day.
When you do take your vitamins and minerals, take them with
food. In order to be effective, vitamins, minerals, and trace
metals need to chemically interact with food.

ATN: What about exercise?

KW: One of the simplest things we recommend is for folks to
just walk and swing their arms. When watching TV, it's a
simple matter to pick up soup cans or something like that --
or putting a two to five pound weight on your foot and
lifting it. Low resistance, many repetitions, is the key so
the movement doesn't exhaust you but does stimulate the
muscles.

ATN: Because if you don't use it, you'll lose it?

KW: Yes, muscle tends to be exchanged for fat. We want to
take a look at what impact exercise is going to have on the
development and maintenance of lean body mass. Currently we
don't have much data to go on.

Dr. Hellerstein here is doing work with anabolic steroids.
The problem with some of the steroids is that they may put
some weight on you, but unless you are exercising it will be
mostly fat, not lean body mass. But on the other side, people
with HIV disease often fatigue easily, so you can't expect
them to have a rigorous routine.

ATN: What about differences between men and women?

KW: In a Rhode Island study, the diagnosis of wasting
syndrome was the second most common index diagnosis of AIDS
in women. Moreover, women were greater than two and a half
times more likely than gay men to have the diagnosis of
wasting. To my knowledge, studies have not been conducted to
determine whether the pattern of weight loss, i.e., muscle
loss and fat preservation, is the same for women as it is for
men.

ATN: What can you bring to our readers about options, a note
of optimism, things to think about?

KW: The key again is to start working with people early in
HIV disease, because we have a much better chance of keeping
them nutritionally sound if we start earlier rather than
later. We have also seen the possibility of moving someone
from merely surviving, because they're so weak from
malnutrition, to living a meaningful life due to optimal
nutrition. We shouldn't give up hope; help is out there.

I think the pervasive attitude is that weight loss and
malnutrition are inevitable. You see that in both the health
care provider and the client perspective. It is important for
folks to hear that there is work being done in the field of
nutrition and HIV disease. Moreover, creative and
individualized approaches to symptoms which interfere with
optimal nutrient intake can be successful.

Nutritional Resources

The following list of nutritional information was prepared in
conjunction with the interview with Kristin Weaver, above.

Upcoming Conference

Third International Symposium on Nutrition and HIV/AIDS,
Philadelphia, October 13-14.

Organized by the Physicians Association for AIDS Care (see
below), Philadelphia FIGHT (community-based research trials
group), and the Pennsylvania AIDS Education and Training
Center, this meeting includes many faculty members who are
leading experts in the field. According to conference
materials the symposium objectives are: "to disseminate the
latest scientific information about the role of nutrition in
the course of HIV disease and the prevention and treatment of
AIDS-associated malnutrition; to improve the knowledge of
those responsible for reimbursement decisions affecting
nutritional strategies for insurance companies, managed care
organizations, state Medicaid agencies, and Medicare
administrators; to provide a forum to exchange information
and to examine research, policy, management, and practice
issues; and to improve communications between researchers and
the users of research."

Registration costs $75.00 and will be limited; organizers
suggest registration by September 15th. For more information
contact: Monica Patel, Philadelphia FIGHT, 201 North Broad
St., 6th Floor, Philadelphia, PA, 19107, 215/557-8265.

How to Get Rehydration Salts

Oral rehydration salts based on the World Health Organization
(WHO) formula are available in pharmacies and directly from
Jianas Brothers, 2533 Southwest Blvd., Kansas City, MO 64108-
2395, 816/421-2880, fax [phone]. The cost is about 50
cents per packet which dissolves in one liter of water.

Food Safety and Nutrition Advice and Referrals

CDC National AIDS Clearinghouse, 800/458-5231.

Persons may request the free brochure "Eating Defensively.
Food Safety Advice for Persons with AIDS." The materials
prepared by the Food and Drug Administration for the general
public are intended to help individuals lower the risk of
food-borne illness. This includes information on how to avoid
food poisoning, food handling and preparation, and tips for
traveling abroad, shopping, and dining out. A fifteen minute
video is also available for $12.00.

Consumer Nutrition Hotline, 800/366-1655.

Sponsored by the American Dietetic Association. Callers can
speak with a registered dietitian, or ask for a referral to a
registered dietitian. Referrals can be made to practitioners
with specific specialties but callers need to know that the
referral database contains only registered dietitians who
have paid a fee to be included; it is not comprehensive.
Clinics, hospital dietetic departments, public health
departments, and AIDS service organizations may also be able
to provide referrals. Diet counseling is not offered on the
hotline, only general nutrition information.

Meat and Poultry Hotline, 800/535-4555.

This hotline, a service of the U.S. Department of
Agriculture, is staffed by home economists and registered
dietitians, Monday through Friday, 10:00 a.m. to 4:00 p.m.,
EST. Callers can get information about food safety. During
other hours, a voice mail response system provides answers to
commonly asked questions.

Nutritional Counseling

San Francisco Area: Bay Area Nutrition Counseling Center and
Clinic, University of California San Francisco, San Francisco
General Hospital.

Patients are evaluated in-person by a physician and a
dietitian at an initial visit and followed monthly
thereafter. In addition to in- depth evaluation and
counseling, clients receive a personalized manual outlining
the results of laboratory and dietary assessments and the
prescribed nutritional care plan, as well as extensive
practical information. For more information or to schedule an
appointment, contact Violet Garcia, patient liaison, 415/206-
8822.

Illinois: The Cutting Edge.

Under the direction of Cade Fields Gardner, RD (formerly Cade
Fields Newman, RD), this organization provides education for
professional dietitians and patients, nationwide referral,
and direct patient care. The multidisciplinary approach
emphasizes a healthcare team approach to treating individuals
with HIV disease. This includes cooperative involvement by
physicians, social workers, pharmacists, dentists, and other
healthcare providers in a variety of settings. Services are
available in several languages. Physician referral required.
Contact: The Cutting Edge, P.O. Box 922, Carey, IL 60013,
708/516-2455, fax [phone].

[Editor's note: These are two nutritional counseling centers
that we contacted while writing this article. Many others
could be listed as well.]

Professional Organizations and Selected Resource Materials

American Society for Parenteral and Enteral Nutrition
(ASPEN).

This is a multidisciplinary, professional, and scientific
organization working to promote quality patient care,
education, and research in the field of nutrition and
metabolic support. Many peer-reviewed periodical and
reference materials are available including Standards and
Clinical Guidelines (for physicians, nurses, dietitians, and
pharmacists). For a complete list of publications and
programs contact: ASPEN, 8630 Fenton St., Suite 412, Silver
Spring, MD 20910, 301/587-6315, fax [phone].

Physicians Association for AIDS Care.

In addition to their monthly journal, they have available
Nutrition and HIV/AIDS: Proceedings of the 1992 International
Symposium on Nutrition and HIV/AIDS, including the
Nutritional Algorithm and the Nutritional Initiative of the
Physicians Association for AIDS Care. This technical volume
includes articles by some of the most respected experts in
the field of nutrition and HIV, including Donald Kotler,
Richard Beach, Cade Fields Newman, and Mark Hellerstein.
Topics covered include nutrition and wasting, metabolic
changes in HIV disease, and issues specific to developing
countries. It also includes "An Overview of the PAAC
Initiative," which presents strategies for coping with
nutritional problems and an in-depth bibliography. ($25.00
including shipping and handling.) Contact: PAAC Publishing,
Inc., 101 W. Grand Ave., Suite 200, Chicago, IL 60610,
312/222-1326, toll-free 800/243-3059, fax [phone].

For less technical information, HIV Disease Nutrition
Guidelines: Practical Steps for a Healthier Life presents
practical information focusing on good nutrition, regular
exercise, and stress management. Also included are
recommendations for dealing with commonly occurring symptoms
of HIV disease. It is published by the Physicians Association
for AIDS Care with an educational grant from Stadtlanders
Pharmacy. Free copies are available in English or Spanish
from Stadtlanders Pharmacy, 800/238-7828.

Bibliography and References

Baum MK, Shor-Posner G, Bonvehi P, and others. Influence of
HIV infection on vitamin status and requirements. Annals of
the New York Academy of Sciences. September 30, 1992; volume
669, pages165-173, and discussion on pages 173-174.

Beach RS, Mantero-Atienza E, Shor-Posner G, and others.
Specific nutrient abnormalities in asymptomatic HIV-1
infection. AIDS. July 1992; volume 6, number 7, pages 701-
708.

Beach RS, Morgan R, Wilkie F, and others. Plasma vitamin B12
level as a potential cofactor in studies of human
immunodeficiency virus type1-related cognitive changes.
Archives of Neurology. May 1992; volume 49, number 5, pages
501-506.

Carpenter CC, Mayer KH, Fisher A, Desai MB, and Durand L
Natural history of AIDS in Rhode Island. American Journal of
Medicine. June 1989; volume 86, number 6 part 2, pages 771-
775.

Chandra, RK. Micronutrients and immune functions: An
overview. Annals of the New York Academy of Sciences. 1990;
volume 587, pages 9-16.

Chlebowski RT, Grosvenor MB, Bernhard NH, Morales LS, and
Bulcavage LM. Nutritional status, gastrointestinal
dysfunction, and survival in patients with AIDS. American
Journal of Gastroenterology. October 1989; volume 84, number
10, pages 1288-1293.

Grunfeld C and Feingold KR. Metabolic disturbances and
wasting in the acquired immunodeficiency syndrome. New
England Journal of Medicine. July 30, 1992; volume 327,
number 5, pages 329-337.

Kotler DP. Nutritional effects and support in the patient
with acquired immunodeficiency syndrome. Journal of
Nutrition. March 1992; volume 122, number 3 (supplement),
pages 723-727.

Kotler DP, Tierney AR, Wang J, and Pierson RN Jr. Magnitude
of body-cell-mass depletion and the timing of death from
wasting in AIDS. American Journal of Clinical Nutrition.
September 5, 1989; volume 50, number 3, pages 444-447.

Smith E and Orbolm M. Trends and patterns of opportunistic
diseases in Danish AIDS patients, 1980-1990. Scandinavian
Journal of Infectious Diseases. 1990; volume 22, number 6,
pages 665-672.


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