Table 1 Update of Phase IIB/III clinical trials, April 2006
Network | Products | Design | Population | Endpoints | Progress to date |
|---|---|---|---|---|---|
Population Council | Carraguard Placebo | Ph III RCT | 3 sites 6639 16–40 years | HIV | 6000 accrued |
HIV Prevention Trials Network (HPTN 035) | BufferGel PRO 2000 0.5% Placebo Condom only | Ph II/IIb safety and effectiveness RCT | 5 sites; 800 (Ph II); | Safety; HIV | 827 accrued |
CONRAD | CS 6% Placebo | Ph III RCT | 4 sites 2574 HR women | HIV CT, GC | 738 accrued |
Microbicides Development Programme (MDP) | PRO 2000 0.5% PRO 2000 2% Placebo | Ph III RCT | 5 sites 9673 | HIV HSV, GC | 640 accrued |
Family Health International (FHI) | CS 6% Placebo | Ph III RCT | 2 sites 2160 HR women | HIV CT, GC | 1102 accrued |
Methods for Improving Reproductive Health in Africa (MIRA) | All flex diaphragm with Replens Condom only | Open-label RCT | 5000 | HIV HSV2 CT, GC, TV Acceptability | Completed accrual; |
Family Health International (FHI) | C31G 1% Placebo | Ph III RCT | 4284 HR women | HIV | Ghana closed Feb-06 2100 accrued Nigeria |