A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
This study has been completed.
Sponsor:
International Partnership for Microbicides, Inc.
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00303576
First received: March 15, 2006
Last updated: July 28, 2006
Last verified: July 2006
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![](https://webarchive.library.unt.edu/web/20130305102053im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: dapivirine (TMC120) vaginal gel |
Phase 1 Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | A Phase I/II Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by International Partnership for Microbicides, Inc.:
![](https://webarchive.library.unt.edu/web/20130305102053im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- HIV-negative
- Willing to participate and sign an informed consent
- Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
- Willing to use two forms of contraception during the study.
- Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
- Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses.
- Willing to abstain from using any vaginal product (other than the study product or placebo).
- Willing to be sexually abstinent from randomization until completion of Day 7 evaluations.
Exclusion Criteria:
- Currently pregnant or breast-feeding.
- Clinically detectable genital abnormality on the vulva, vaginal walls or cervix.
- Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed genital ulcer disease or active HSV-2 lesions.
- Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization.
- Symptomatic bacterial vaginosis and unwilling to undergo treatment.
- Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
![](https://webarchive.library.unt.edu/web/20130305102053im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303576
Locations
Rwanda | |
Projet Ubuzima | |
Kigali, Rwanda | |
South Africa | |
Reproductive Health Research Unit - Sheshisani IPM Clinic | |
Yeoville, Johannesburg, South Africa | |
Farmovs-Parexel | |
Bloemfontein, South Africa | |
Tanzania | |
Kilimanjaro Reproductive Health Program | |
Moshi, Tanzania |
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: | Zeda Rosenberg, ScD | IPM |
![](https://webarchive.library.unt.edu/web/20130305102053im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00303576 History of Changes |
Other Study ID Numbers: | IPM003 |
Study First Received: | March 15, 2006 |
Last Updated: | July 28, 2006 |
Health Authority: | South Africa: Medicines Control Council Tanzania: Food and Drug Authority Rwanda: Ministry of Health |
Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1 HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 03, 2013