Clinical Trials
IPM’s clinical trials are carried out sequentially: first to determine the safety of a product and then to test its efficacy, or ability to prevent HIV infection. Our initial safety trials, Phase I trials, involve small numbers of women under carefully controlled clinical conditions. Expanded safety trials, Phase I/II, are then conducted to gain additional safety data among more participants over longer periods of time. When the safety trials are complete, longer-term safety and efficacy trials are conducted.
IPM conducts its clinical trials according to the highest safety and ethical principles, in partnership with researchers and communities.
Clinical Trials Table
June 2022
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| IPM 001 | Dapivirine ring safety (Ring-001) | Belgium | 12 women | Completed |
| IPM 007 | Seroconverter protocol | South Africa, Uganda | n/a | Completed |
| IPM 008 | Dapivirine ring safety (Ring-002) | Belgium | 13 women | Completed |
| IPM 011 | Placebo ring safety & acceptability | South Africa, Tanzania | 170 women | Completed |
| IPM 013 | Dapivirine ring PK (Ring-004) | Belgium | 48 women | Completed |
| IPM 015 | Dapivirine ring safety (Ring-004) | Kenya, Malawi, South Africa, Tanzania | 280 women | Completed |
| IPM 018 | Dapivirine ring PK (Rings 002 & 003) | Belgium | 24 women | Completed |
| IPM 024 | Dapivirine ring PK (Ring-004) | Belgium | 16 women | Completed |
| IPM 027 (The Ring Study) | Dapivirine ring long-term safety and efficacy (Ring-004) | South Africa, Uganda | 1950 women | Completed |
| IPM 028 | Dapivirine ring drug-drug interaction (Ring-004) | Belgium | 36 women | Completed |
| IPM 029 | Dapivirine ring & male condom functionality (Ring-004) | United States | ~70 couples | Completed |
| IPM 033 | Dapivirine ring & female condom functionality (Ring-004) | United States | ~80 couples | Completed |
| IPM 034 | Dapivirine Ring PK (Ring-004) | Belgium | 40 women | Completed |
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| MTN 013 / IPM 026 | Maraviroc, dapivirine, and dapivirine-maraviroc combination ring | United States | 48 women | Completed |
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| IPM 003 | Dapivirine gel safety (Gel-002) | Rwanda, South Africa, Tanzania | 112 women | Completed |
| IPM 004 | Dapivirine gel PK (Gel-002) | South Africa | 18 women | Completed |
| IPM 005B | Dapivirine gel safety (Gel-002) | Belgium | 36 women | Completed |
| MTN 012 / IPM 010 | Dapivirine gel male tolerance (Gel 4759) | United States | 48 men | Completed |
| IPM 012 | Dapivirine gel PK (Gels 4750 & 4789) | Belgium | 36 women | Completed |
| IPM 014A | Dapivirine gel safety (Gel 4759) | Kenya, Malawi, Rwanda, South Africa | 280 women | Completed |
| IPM 014B | Dapivirine gel safety (Gel 4789) | South Africa | 100 women | Completed |
| IPM 020 | Dapivirine gel safety (Gels 4759 & 4789) | United States | 128 women | Completed |