A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00303576 |
Recruitment Status
:
Completed
First Posted
: March 17, 2006
Last Update Posted
: July 31, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: dapivirine (TMC120) vaginal gel | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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. |
Study Start Date : | October 2005 |
Study Completion Date : | July 2006 |

- Local and systemic safety and tolerability.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303576
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 |
Study Director: | Zeda Rosenberg, ScD | IPM |
ClinicalTrials.gov Identifier: | NCT00303576 History of Changes |
Other Study ID Numbers: |
IPM003 |
First Posted: | March 17, 2006 Key Record Dates |
Last Update Posted: | July 31, 2006 |
Last Verified: | July 2006 |
Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1 HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Anti-Infective Agents |