A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
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ClinicalTrials.gov Identifier: NCT00309205 |
Recruitment Status :
Completed
First Posted : March 31, 2006
Last Update Posted : September 1, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections HIV-1 | Drug: dapivirine (TMC120) vaginal gel | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women. |
Study Start Date : | December 2005 |
- 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 form
- 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
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 GUD or active HSV-2 lesion
- Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
- Symptomatic bacterial vaginosis at Screening 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): NCT00309205
Belgium | |
SGS Biopharma - Research Unit Stuivenberg | |
Antwerp, Belgium, 2060 |
Study Director: | Zeda Rosenberg, ScD | IPM |
Responsible Party: | Zeda Rosenberg ScD, International Partnership for Microbicides |
ClinicalTrials.gov Identifier: | NCT00309205 |
Other Study ID Numbers: |
IPM005B |
First Posted: | March 31, 2006 Key Record Dates |
Last Update Posted: | September 1, 2009 |
Last Verified: | August 2009 |
HIV seronegativity |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Dapivirine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |