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IPM is studying and testing a number of potential drugs and innovative drug delivery methods, among them:
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Dapivirine – Vaginal Gel: IPM is conducting microbicide safety trials at clinical sites in Belgium, Rwanda, South Africa and Tanzania to test the safety and acceptability of dapivirine (TMC120 gel), an antiretroviral compound designed to prevent or interrupt HIV replication in human cells. |
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Dapivirine – Vaginal Ring Delivery: IPM is researching dapivirine’s use in an innovative vaginal ring delivery system following two successful safety studies (IPM001 in 2004 and IPM008 in 2005) which showed the rings to be a viable drug delivery method. An effective vaginal ring delivery system could be highly beneficial to women by offering them extended HIV protection, possibly for weeks or even months. |
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Other Drugs: IPM is developing additional compounds licensed from Merck & Co, Inc. and Bristol-Myers Squibb and is continuing to expand its pipeline so that more clinical trials in the future will be conducted using new drugs and/or combinations of drugs. |
View a complete list of IPM clinical trials and their status
Clinical research must be conducted in full partnership with host-country communities. In all aspects of clinical trial planning, IPM works closely with local partners on protocol development, recruitment and implementation. Additionally, every IPM-sponsored trial site works with a community advisory board to learn about community perspectives and to engage community members as partners. IPM works closely with local policy makers to foster ownership and commitment to the clinical trial process for all of its clinical trials.
IPM follows strict ethical guidelines in conducting all of its clinical trials, including the watershed principles defined by ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (see box).
IPM has also developed comprehensive guidelines for the conduct of its clinical trials through a rigorous ethical and peer review process. These guidelines detail a commitment to provide all study participants with ongoing risk reduction counselling, male and female condoms, treatment for those who become infected with HIV during the course of the trial, and treatment and compensation in the unlikely event physical harm results from trial participation. For more information, read the Guidelines for the Conduct of IPM’s Clinical Trials.
Read IPM’s Issue Brief on Clinical Trials
(as of October 2008)
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| Study Protocol |
Study Name &
Location |
Number of volunteers |
Status &
Reports |
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| IPM 001 |
Dapivirine intravaginal ring safety
Belgium |
12 |
Completed, 2004-05
Poster (CROI 2007) |
| IPM 003 |
Dapivirine gel safety
Rwanda, South Africa, Tanzania |
112 |
Completed, 2005-06
Abstract (M2008) |
| IPM 004 |
Dapivirine gel PK
South Africa |
18 |
Completed, 2005-06
Abstract (M2008) |
| IPM 005B |
Dapivirine gel safety
Belgium |
36 |
Completed, 2005-06 Abstract (ICAAC 2007) |
| IPM 007 |
Seroconverter protocol
TBD |
N/A |
Planned |
| IPM 008 |
Dapivirine intravaginal ring safety
Belgium |
13 |
Completed, 2005 Abstract (AIDS 2006) |
| IPM 009 |
Dapivirine efficacy
TBD |
TBD |
Planned |
| IPM 010 |
Dapivirine gel male tolerance
TBD |
TBD |
Planned |
| IPM 011 |
Placebo intravaginal ring safety & acceptability
South Africa, Tanzania
Kenya |
200 |
Ongoing, 2007-08
Follow-up |
| IPM 012 |
Dapivirine gel PK
Belgium |
36 |
Data analysis |
| IPM 013 |
Dapivirine intravaginal ring PK
Belgium |
96 |
Planned |
| IPM 014A |
Dapivirine gel safety
Kenya, Malawi, Rwanda, South Africa, Tanzania |
320 |
Planned |
| IPM 014B |
Dapivirine gel safety
Kenya, Malawi, Rwanda, South Africa, Tanzania, Zambia |
320 |
Planned |
| IPM 015 |
Dapivirine intravaginal ring safety
Kenya, Malawi, Rwanda, South Africa, Tanzania, Zambia |
280 |
Planned |
| IPM 018 |
Dapivirine intravaginal ring PK
Belgium |
24 |
Completed, 2007
Poster (CROI 2008) |
| IPM 020 |
Dapivirine gel safety
United States |
150 |
Planned |
| IPM 021 |
Dapivirine intravaginal ring safety
Germany, Netherlands, United Kingdom |
120 |
Planned |
| IPM 022 |
Smart applicator pilot
South Africa, United States |
113 |
Planned |
| IPM 023 |
Dapivirine gel safety
Belgium |
72 |
Planned |
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