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| Sponsor: | International Partnership for Microbicides, Inc. |
|---|---|
| Information provided by: | International Partnership for Microbicides, Inc. |
| ClinicalTrials.gov Identifier: | NCT00917904 |
Purpose
The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Acquired Immunodeficiency Syndrome Healthy |
Drug: dapivirine gel 4789, 0.05%, 2.5g Drug: vehicle placebo gel, 2.5g |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4789, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women. |
| Estimated Enrollment: | 320 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| vehicle placebo gel: Placebo Comparator |
Drug: vehicle placebo gel, 2.5g
dosage form: vaginal gel frequency: once daily duration: 6 weeks
|
| dapivirine gel: Experimental |
Drug: dapivirine gel 4789, 0.05%, 2.5g
dosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks
|
To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014B is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Madi Albertse | +27 (0) 21 860 2300 | malbertse@ipm-microbicides.org.za |
| Kenya | |
| Kenya Medical Research Institute | Not yet recruiting |
| Kisumu, Kenya | |
| Principal Investigator: Dr Elizabeth Bukusi | |
| Sub-Investigator: Dr Maureen Adudans | |
| Sub-Investigator: Dr. Craig Cohen | |
| Sub-Investigator: Dr. Betty Njoroge | |
| Malawi | |
| Johns Hopkins Project, College of Medicine | Not yet recruiting |
| Blantyre, Malawi | |
| Principal Investigator: Dr Bonus Makanani | |
| Sub-Investigator: Dr Luis Gadama | |
| Rwanda | |
| Projet Ubuzima | Not yet recruiting |
| Kigali, Rwanda | |
| Contact: Joseph Vyankandondera, MD +250 503431 vyankajo@yahoo.fr | |
| Principal Investigator: Dr. Joseph Vyankandondera | |
| Sub-Investigator: Janneke van de Wijgert, PhD | |
| Sub-Investigator: Dr Justin Ntirushwa | |
| South Africa, Eastern Cape | |
| Be Part Clinic, Mbekweni | Recruiting |
| Paarl, Eastern Cape, South Africa | |
| Principal Investigator: Dr Elizabeth Hellstrom | |
| Sub-Investigator: Dr. Chrisna Anderson | |
| Sub-Investigator: Dr. Cornelis Grobelaar | |
| Sub-Investigator: Dr. Inge Paschke | |
| South Africa, KwaZulu Natal | |
| Qhakaza Mbokodo | Not yet recruiting |
| Ladysmith, KwaZulu Natal, South Africa | |
| Principal Investigator: Dr. Joshua Matambo | |
| Principal Investigator: Dr. Philip Kotze | |
| Sub-Investigator: Dr. Sidney Sibiya | |
| Prevention for HIV and AIDS Project | Not yet recruiting |
| Pinetown, KwaZulu Natal, South Africa | |
| Principal Investigator: Dr. Derek Arbuckle | |
| Sub-Investigator: Dr. Michael Robinson | |
| South Africa, North West Province | |
| Madibeng Centre for Research | Recruiting |
| Brits, North West Province, South Africa | |
| Principal Investigator: Dr. Cheryl Louw | |
| Sub-Investigator: Dr Francis Anthonyrajah | |
| Sub-Investigator: Prof. Johannes Hugo, MBChB | |
| South Africa, Western Cape | |
| Desmond Tutu HIV Foundation, Masiphumelele | Recruiting |
| Cape Town, Western Cape, South Africa, 7975 | |
| Principal Investigator: Dr. Linda-Gail Bekker | |
| Sub-Investigator: Dr. Jennifer Pitt | |
| Desmond Tutu HIV Foundation, Nyanga | Not yet recruiting |
| Cape Town, Western Cape, South Africa | |
| Principal Investigator: Dr. Linda-Gail Bekker | |
| Sub-Investigator: Dr Danielle Crida | |
| Sub-Investigator: Dr. Llewellyn Fleurs | |
| Sub-Investigator: Dr. Andrew Scheibe | |
| Sub-Investigator: Dr. Jennifer Pitt | |
| Tanzania | |
| Kilimanjaro Christian Medical Centre | Not yet recruiting |
| Moshi, Tanzania | |
| Contact: Tara Mtuy +255 272 750663 | |
| Principal Investigator: Dr Gileard Masenga | |
| Principal Investigator: Prof Saidi Kapiga | |
| Sub-Investigator: Dr Sarah Chiduo | |
| Sub-Investigator: Dr Charles Mmbando | |
| Study Director: | Dr Annalene Nel | IPM |
More Information
| Responsible Party: | IPM ( Zeda Rosenberg, ScD ) |
| Study ID Numbers: | IPM 014B |
| Study First Received: | June 8, 2009 |
| Last Updated: | December 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00917904 History of Changes |
| Health Authority: | South Africa: Medicines Control Council; Tanzania: Food & Drug Administration; Malawi: College of Medicine Research and Ethics Committee; Kenya: Ministry of Health; Rwanda: Ethics Committee |
|
HIV Infections Acquired Immunodeficiency Syndrome Healthy HIV seronegativity |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Disease Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |