REMUNE® CLINICAL TRIALS IN THAILAND
(Last Updated : December 23,2004) PROTOCOL 2101B Title A Phase II Double-Blind, Randomized, Adjuvant-Controlled Study of the HIV-1 Immunogen on Safety and Immunogenicity in HIV-1 Infected Subjects in Thailand P2101B | 40 Weeks | Population | 297 Volunteers in five different clinical sites | Trial Period | 40 Weeks (Day 1 to Week 40) | Immunization Schedule | 12-Week Intervals | Randomization | 2:1 Ratio HIV-1 Immunogen (REMUNE®) and placebo |
P2101B Extension | Two Years Extension Study (132 Weeks) | Population | 223 Volunteers previously enrolled in P2101B | Trial Period | Week 48 - Week 132 | Immunization Schedule | 12 - Week Intervals (Open-label REMUNE® dosing) |
P2101B Extended Phase II | Additional Two-Years Extension Study (232 Weeks) | Population | 186 Remaining Volunteers from P2101B Extension | Trial Period | Up to 232 Weeks | Immunization Schedule | 12 - Week Intervals (Open-label REMUNE® dosing) |
Cohort Overall, there are nine (9) cohorts comprising the clinical trial. A total of five test sites in Thailand: Bangkok (2), Khon Kaen (1), Chiang Mai (1), and Songkla (1).
Current Status P2101B Extended Phase II (232 Weeks) study ended in May 2003. As of December 2004; data collection, clarification and verification are already completed. Part of the results have already been published while the complete report is are under preparation.
Publications - A Double-Blind, Adjuvant-Controlled Trial of Human Immunodeficiency Virus Type 1 (HIV-1) Immunogen (Remune) Monotherapy in Asymptomatic, HIV-1 Infected Thai Subjects with CD4-Cell Counts of > 300
Clinical and Diagnostic Laboratory Immunology (CDLI) Journal September 2000. Vol. 7, No. 5, 728-733. - Long-Term Follow-Up of HIV-1-Infected Thai Patients Immunized with Remune® Monotherapy
HIV Clinical Trials (HCT) Journal 2001; 2(5): 391-398 - Delayed Progression to AIDS in Volunteers Treated with Long-Term HIV-1 Immunogen (REMUNE® ) Therapy in Thailand
HIV Medicine 2004; 5(5) : 317-325 - Therapeutic vaccine trials in Thailand (Leading Article Section in HIV Therapeutic Journal)
Journal of HIV Therapy September 2004; 9(3) : 57 - 59
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