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IPM Clinical Trials

IPM is studying and testing a number of potential drugs and innovative drug delivery methods, among them:

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.
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.
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

Partnering with Local Communities

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.

Guidelines for Conducting 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

 

IPM Clinical Trials
(as of June 2008)

Study Protocol Study Name &
Location
Number of volunteers Status &
Reports
IPM001 Dapivirine intravaginal ring safety
Belgium
12

Completed, 2004-05
Poster (CROI 2007)

IPM003 Dapivirine gel safety
Rwanda, South Africa, Tanzania
112 Completed, 2005-06
Abstract (M2008)
IPM004 Dapivirine gel PK
South Africa
18 Completed, 2005-06
Abstract (M2008)
IPM005B Dapivirine gel safety
Belgium
36 Completed, 2005-06
Abstract (ICAAC 2007)
IPM007 Seroconverter protocol
Various
N/A Planned, 2009
IPM008 Dapivirine intravaginal ring safety
Belgium
13 Completed, 2005
Abstract (AIDS 2006)
IPM009 Dapivirine efficacy
Various
TBD Planned, 2010
IPM010 Dapivirine gel male tolerance
Belgium
36 Planned, 2009
IPM011 Placebo intravaginal ring safety & acceptability
South Africa, Tanzania
200 Ongoing, 2007-08
IPM012 Dapivirine gel PK
Belgium
36 Ongoing, 2007-08
IPM013 Dapivirine intravaginal ring PK
Belgium
60 Planned, 2009
IPM014A Dapivirine gel safety
Malawi, South Africa, Tanzania
320 Planned, 2009
IPM014B Dapivirine gel safety
Malawi, South Africa, Tanzania
320 Planned, 2008
IPM015 Dapivirine intravaginal ring safety
South Africa, Tanzania
280 Planned, 2009
IPM017 Dapivirine intravaginal ring safety
Belgium
46 Planned, 2009
IPM018 Dapivirine intravaginal ring PK
Belgium
24 Completed, 2007
Poster (CROI 2008)
IPM020 Dapivirine gel safety
United States
150 Planned, 2008
IPM021 Dapivirine intravaginal ring safety
Europe
120 Planned, 2009
IPM022 Smart applicator validation study
United States
113 Planned, 2008
IPM023 Dapivirine gel safety
Belgium
72 Planned, 2008


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