IPM 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. When the safety trials are complete, longer-term safety and efficacy trials are conducted.
IPM Clinical Trials Table
February 2013
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| IPM 028 | Drug-drug interaction (Ring-004) | Belgium | 36 women | Ongoing |
| IPM 029 | Male condom functionality (Ring-004) | United States | ~70 couples | Planned |
| IPM 033 | Female condom functionality (Ring-004) | United States | ~80 couples | Planned |
| IPM 001 | Dapivirine ring safety (Ring-001) | Belgium | 12 women | Completed |
| IPM 008 | Dapivirine ring safety (Ring-002) | Belgium | 13 women | Completed |
| IPM 018 | Dapivirine ring PK (Rings 002 & 003) | Belgium | 24 women | Completed |
| IPM 011 | Placebo ring safety & acceptability |
South Africa Tanzania |
170 women | Completed |
| IPM 024 | Dapivirine ring PK (Ring-004) | Belgium | 16 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 027 (The Ring Study) | Dapivirine ring long-term safety and efficacy (Ring-004) |
South Africa TBD |
1650 women | Ongoing |
| IPM 007 | Seroconverter protocol |
South Africa TBD |
n/a | Ongoing |
| 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 |
| IPM 012 | Dapivirine gel PK (Gels 4750 & 4789) | Belgium | 36 women | Completed |
| IPM 020 | Dapivirine gel safety (Gels 4759 & 4789) | United States | 128 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 |
| MTN 012 / IPM 010 | Dapivirine gel male tolerance (Gel 4759) | United States | 48 men | Completed |
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| MTN 013 / IPM 026 | Maraviroc, dapivirine, and dapivirine-maraviroc combination ring | United States | 48 women | Data Analysis |