AEGiS-13IAC: Results of the follow-up study on 297 asymptomatic HIV-infected subjects previously enrolled in the Phase II double-blind, adjuvant-controlled trial of HIV-1 immunogen (Remune) in Thailand.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Results of the follow-up study on 297 asymptomatic HIV-infected subjects previously enrolled in the Phase II double-blind, adjuvant-controlled trial of HIV-1 immunogen (Remune) in Thailand.

Int Conf AIDS 2000 Jul 9-14; 13:23 (abstract no.. LbOr26)

Churdboonchart V, Sakondhavat C, Isarangkura Na Ayudthya B, Kulpradist S, Chandeying V, Rugpao S, Boonshuyar C, Sukeepaisarncharoen W, Sirawaraporn W, Moss R
Remune Clinical Trials in Thailand, Bangkok. Fax: +662 248-4962, E-mail: scvch@mahidol.ac.th.

BACKGROUND: The therapeutic vaccine, Remune, had undergone Phase I and II trials in Thailand in 1999. This reports results of the continuing follow up study done on the subjects previously enrolled in the Phase II trial.

METHODS: The 297 subjects previously enrolled in the 40-week Phase II trial of the Remune are still being monitored in a follow up study. After unblinding, all subjects were given Remune every 12 weeks at Week 48, 60, 72, 84, 96, 108, 120 and 132. The first cohort already completed two years of follow up. Average change in immunological cells, CD4+, body weight, viral load, and humoral immune response by Western blot analysis were done to evaluate the effect of this therapeutic vaccine.

RESULTS: Week 40 results had shown a significant difference result with primary endpoint between the Remune and IFA groups (AUCMB p=.02). At week 88 three cohorts which batch was enrolled first were analyzed and the results on 68 cases with Remune monotherapy showed 29% with significantly lower viral load and significantly higher CD4+ cells, body weight, and CD4+/CD8+ ratio. Thirty-nine subjects had stable viral load. The first cohort already completed 136 weeks of study and results in the responder group showed increased or stable CD4 cells and lower or stable viral load. Antibodies detected by Western blot showed higher and broader activity, indicating a strong correlation to increased immunogenicity, while nonresponders showed very low and decreasing activity.

CONCLUSION: Results of this follow-up study showed that Remune as a monotherapy is a promising treatment. While results from the clinical trial using Remune+HAART showed better outcome, the monotherapy of Remune revealed it useful in restoring immunological cells and control of virus in 30% of treated subjects. Therefore, before using anti-viral drugs, Remune monotherapy may be used first and probably is a cost-effective option.

Keywords: AEGIS, AIDS Vaccines, HIV-1, HIV Infections, Adjuvants, Immunologic, Viral Load, HIV Seropositivity, HIV Envelope Protein gp120, Follow-Up Studies, Antigens, Clinical Trials, Double-Blind Method, Blotting, Western, Antigens, CD4, Thailand, remune, immunology, AIDS
000709
LbOr26