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
November 2018
| 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 | Ongoing |
| 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 |
| MTN-020 (ASPIRE)** | Dapivirine ring safety and effectiveness (Ring-004) | Malawi, South Africa, Uganda, Zimbabwe | 2629 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 |
| MTN 023 / IPM 030 | Dapivirine ring safety (Ring-004) | United States | 96 females | Completed |
| MTN 024 / IPM 031 | Dapivirine ring safety and acceptability (Ring-004) | United States | 96 women | Completed |
| IPM 032 (DREAM) | Dapivirine ring (Ring-004) open-label safety and adherence | South Africa, Uganda | 1100 women | Ongoing |
| MTN-025 (HOPE)** | Dapivirine ring (Ring-004) open-label safety and adherence | Malawi, South Africa, Uganda, Zimbabwe | 1500 women | Ongoing |
| 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 |
| IPM 035 | Dapivirine ring & menses and tampon use (Ring-004) | Belgium | 32 women | Completed |
| IPM 036 | Dapivirine ring drug-drug interaction (Ring-004) | Belgium | 36 women | Completed |
| MTN-029 / IPM 039 | Dapivirine ring PK (Ring-004) | United States | 16 women | Completed |
| MTN-034 (REACH)*** | Dapivirine ring (Ring-004) and oral PrEP safety and adherence | Kenya, South Africa, Uganda, Zimbabwe | 300 females | Planned |
| MTN-043 / IPM 051 | Dapivirine ring (Ring-004) and oral PrEP safety and PK in breastfeeding women | Malawi, South Africa, Uganda, Zimbabwe | 100 women and infants | Planned |
| MTN-042 / IPM 050 | Dapivirine ring (Ring-004) and oral PrEP safety and PK in pregnant women | Malawi, South Africa, Uganda, Zimbabwe | 750 women | Planned |
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| MTN-036/IPM 047 | 3-month dapivirine ring PK and safety (Ring-006, Ring-008) | United States | 48 women | Ongoing |
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| MTN-030/ IPM 041 | Dapivirine-levonorgestrel ring PK and safety | United States | 24 women | Completed |
| MTN-044/ IPM 053/ CCTN 019 | Dapivirine-levonorgestrel ring PK and safety | United States | 24 women | Ongoing |
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| IPM 042 | DS003 tablet safety | Belgium | 36 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 |
|---|---|---|---|---|
| FAME-02*** | Dapivirine film safety and PK | United States | 60 women | Completed |
| FAME-02b** | Dapivirine film safety and PK | United States | 10 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 |
| Trial | Description | Countries | No* | Status |
|---|---|---|---|---|
| CHARM-03** | Maraviroc gel safety and PK | United States | 19 women and men | Completed |