Table 2.
Ongoing and Planned Clinical Trials of Topical Microbicide Candidates (January 2012)
| Phase | Trial name | Candidate(s) | Mechanism of action |
Location | Population |
|---|---|---|---|---|---|
| IIIb | CAPRISA 008 | Tenofovir gel | Replication inhibitor | South Africa | 700 women planned |
| III | MTN020 | Dapivirine vaginal ring | Replication inhibitor | Malawi, South Africa, Uganda, Zambia, Zimbabwe | 3476 women planned |
| IPM 027 | Dapivirine vaginal ring | Replication inhibitor | Kenya, Malawi, South Africa, Rwanda | 1650 women planned | |
| FACTS 001[49] | Tenofovir gel | Replication inhibitor | South Africa | 2200 women | |
| IIb | VOICE[46] | Tenofovir gel; Oral TDF/FTC* | Replication inhibitor | Malawi, South Africa, Uganda, Zimbabwe | 5,000 heterosexual women |
| II | MTN 017 | Reformulated tenofovir gel for rectal use | Replication inhibitor | Peru, South Africa, Thailand, United States | 216 men who have sex with men planned |
| I/II | IPM 015[53] | Dapivirine vaginal ring | Replication inhibitor | South Africa, Kenya, Malawi, Rwanda, Tanzania | 280 women |
| IPM 014A[54] | Dapivirine vaginal gel | Replication inhibitor | Kenya, Malawi, Rwanda, South Africa | 320 women | |
| IPM 014B[54] | Dapivirine vaginal gel | Replication inhibitor | South Africa | 320 women | |
| IPM 020[55] | Dapivirine vaginal gel | Replication inhibitor | United States | 180 women | |
| I | AF 020[51] | Amphora™/ ACIDFORM™ gel | Barrier / Maintenance of normal vaginal defences | United States | 36 women |
| MTN 012 / IPM 010 [56] | Dipivarine vaginal gel | Replication inhibitor | United States | 48 men | |
| MTN 013 / IPM 026 [57] | Dapivirine and miraviroc vaginal ring | Replication inhibitor | United States | 48 women | |
| MTN 007[58] | Reformulated Tenofovir gel for rectal use | Replication inhibitor | United States | 63 women and men | |
| Project gel[59] | Tenofovir gel | Replication inhibitor | US, Puerto Rico | 240 MSM |
Note the tenofovir gel, and oral TDF arms in this study were prematurely halted for futility. The FTC arm is continuing
Adapted from the Global Advocacy for HIV prevention tables on ongoing and planned clinical trials – http://www.avac.org/ht/d/sp/i/3512/pid/3512