Document 2779
 DOCN  M94A2779
 TI    Immunotherapy with rgp160 (VaxSyn), and AZT, in asymptomatic
       HIV-infected individuals.
 DT    9412
 AU    Aiuti F; Pontesilli O; Guerra E; Ricci G; Varani AR; Carlesimo M; Scala
       E; Mollicone B; Giovannetti A; Pandolfi F; et al; Univ. of Rome La
       Sapienza, Italy.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):227 (abstract no. PB0337). Unique
       Identifier : AIDSLINE ICA10/94369796
 AB    OBJECTIVE: To evaluate the effects of gp160 (VaxSyn, MicroGeneSys Inc.,
       Meridien CT, USA) immunotherapy in association or not with AZT on safety
       and immuno-virological markers, in asymptomatic HIV-infected patients
       with CD4 counts > 400 and < 600 cells/mm3. METHODS: 100 patients have
       been randomized to 3 treatment groups: 1) VaxSyn+Placebo AZT, 2)
       VaxSyn+AZT, 3) Placebo VaxSyn (Alum)+AZT. Immunological response, viral
       load, clinical evolution of disease, adverse experiences and
       reactogenicity are monitored. RESULTS: Characteristics at entry of the
       patients are: mean age 31.9 years (+/- 6.0); 69 males, 31 females. Of
       151 study events reported 33 (21.8%) were minor discomforts at injection
       site, headache was reported 27 times (17.8%), and nausea 12 times
       (7.9%). At entry, CD4 cells were 487 +/- 99/mm3 and CD8 cells 1052 +/-
       534/mm3. No significant changes were observed after six months of
       treatment in the whole study population (473 +/- 87 and 965 +/- 499
       cells/mm3 respectively). The ratio CD45RA+/CD45R0+ in the CD4 lymphocyte
       population was 1.42 +/- 0.86 at entry and 1.50 +/- 0.76 after six
       months. Lymphoproliferative response to gp160 was found in 13.1% of the
       subjects at enrollment and a significant increase of it in 44% after 3-6
       months of treatment. DISCUSSION AND CONCLUSIONS: The results of 9 months
       of follow-up indicate that association of VaxSyn and AZT treatment is
       well tolerated. Modifications of env-specific responses and no major
       changes of immunological parameters are seen in the study population
       after 6 months. Unblinded analysis of laboratory data and long-term
       follow-up of the patients are needed to assess treatment efficacy.
 DE    Adult  AIDS Vaccines/ADVERSE EFFECTS/*THERAPEUTIC USE  Combined Modality
       Therapy  Comparative Study  Female  Gene Products, env/ADVERSE
       EFFECTS/*THERAPEUTIC USE  Human  HIV Infections/DRUG THERAPY/*THERAPY
       *Immunotherapy, Active  Leukocyte Count  Male  Protein
       Precursors/ADVERSE EFFECTS/*THERAPEUTIC USE  Recombinant
       Proteins/ADVERSE EFFECTS/THERAPEUTIC USE  T-Lymphocyte Subsets
       Treatment Outcome  Vaccines, Synthetic/ADVERSE EFFECTS/*THERAPEUTIC USE
       Zidovudine/*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).