home
***
CD-ROM
|
disk
|
FTP
|
other
***
search
/
Shareware Overload Trio 2
/
Shareware Overload Trio Volume 2 (Chestnut CD-ROM).ISO
/
dir26
/
med9410o.zip
/
M94A2814.TXT
< prev
next >
Wrap
Text File
|
1994-10-25
|
3KB
|
41 lines
Document 2814
DOCN M94A2814
TI Therapeutic gp160 vaccine (VaxSyn) in adults with CD4 counts < 400/mm3.
Massachusetts DPH gp160 Working Group.
DT 9412
AU DeMaria A; Coady W; Cohen C; Epstein P; Kunches L; Mayer K; Werner B;
Mass. Department of Public Health, Jamaica Plain 02130.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):219 (abstract no. PB0307). Unique
Identifier : AIDSLINE ICA10/94369761
AB To evaluate the safety and immunogenicity of recombinant gp160 vaccine
(VaxSyn, MicroGeneSys) in more advanced HIV disease, 140 patients with
CD4 counts < 400/mm3 are being evaluated in 4 treatment groups. Patients
with 200-400 CD4 count (n = 90) are randomized to 7 monthly VaxSyn
injections of either: A) 160 mcg, B) 160 mcg with interferon gamma [5
mil u sc], or C) 640 mcg; all patients with CD4 count < 200 (n = 50)
receive 640 mcg. Enrollment to date (n = 118) includes 32% women, 37%
people of color, mean age 39 yrs, 24% with AIDS-defining OI, 18%
asymptomatic, 33% not on antiretrovirals at entry. VaxSyn has been well
tolerated, with complaints limited to injection site soreness (38%),
mild fever (12%), myalgia (10%), fatigue (8%). To date, 10% of subjects
have completed the 6-month primary vaccine series after which epitopal
antibody enhancement and skin test response to rgp160 and controls will
be determined. Non-responders after 7 doses may be dose-escalated or
given interferon gamma with VaxSyn doses; responders will receive
boosters bimonthly and be followed for 15 months. To date, there is no
evidence of increased viral activity (from base-dissociated p24 Ag
trends). Complete 6 month immunogenicity data and clinical follow-up
will be presented.
DE Adult AIDS Vaccines/*THERAPEUTIC USE Biological Response Modifiers
Comparative Study Female Gene Products, env/IMMUNOLOGY/*THERAPEUTIC
USE Human HIV Infections/BLOOD/*THERAPY *Immunotherapy, Active
Interferon Type II/THERAPEUTIC USE Leukocyte Count Male Protein
Precursors/IMMUNOLOGY/*THERAPEUTIC USE Recombinant
Proteins/IMMUNOLOGY/THERAPEUTIC USE T4 Lymphocytes Vaccines,
Synthetic/THERAPEUTIC USE CLINICAL TRIAL MEETING ABSTRACT RANDOMIZED
CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).