AEGiS-11IAC: Results of a phase II double-blinded, multicenter, placebo controlled HIV therapeutic vaccine trial.

11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Results of a phase II double-blinded, multicenter, placebo controlled HIV therapeutic vaccine trial.

Int Conf AIDS 1996 Jul 7-12; 11:222 (abstract no. Tu.A.275)
Birx DL, Davis C, Ruiz N, Tamont E, Tacket C, Poretz D, Yangco B, Henry D, Pierce PF, Kerkering T, Gordin F, Thompson M, Luskin-Hawk R, Yarrish R, Holloway W, Deyton L, Robb M, Sitz K, Kim J, Loomis-Price L, Kim S, Michael N, Burke DS, Redfield RR; WRAIR, Rockville MD, USA. Fax: 301-762-4177. E-mail: dbirx@hiv.hjf.org.

The Department of Defense (DoD), collaborating with the National Institutes of Health (NIH) and private infectious disease physicians, began a phase II, randomized double-blind, placebo controlled, multi-center study of recombinant gp 160, formulated by MicroGeneSys, Inc., in 1990.

OBJECTIVES: The objectives of the study were to determine safety, immunogenicity, and clinical efficacy of repeated injections of rgp 160 (MGS) over three to five years.

METHODS: 608 patients were enrolled, each with early stage HIV infection (asymptomatic, CD4 greater than 400) and no antiretroviral therapy. Patients were randomized; half receive rgp 160 injections and half received placebo (alum adjuvant) injections. Following the initial injection series, patients received injections every two months for the duration of the study. The study was completed December 1995, and results were presented to the DSMB in April 1996.

RESULTS: Patients were followed a range of 34-62 months. Of the 608 volunteers enrolled, 483 completed the trial. 17% were lost to follow-up; 104 due to discontinuation and 21 to death. There were a total of 159 primary endpoints reached. 128 volunteers reached a 50% decline in CD4 from baseline and 109 reached a disease progression endpoint (defined as progression to Walter Reed Stage 4, 5, or 6).

CONCLUSIONS: 1) adequate power was achieved for determination of efficacy; 2) small, transient differences in CD4 parameters between vaccine and placebo groups were identified; 3) there was no evidence of these small differences in CD4 parameters affecting disease progression; therefore, there was no evidence of clinical efficacy.

Keywords: AEGIS, AIDS Vaccines, Double-Blind Method, Multicenter Studies, HIV Infections, Single-Blind Method, Placebos, Disease Progression, Antigens, CD4, Immunotherapy, Active, VaxSyn HIV-1 (gp160) vaccine, Human, prevention & control, therapy, ICA11

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TuA275