An Expanded Safety Study of Dapivirine Gel 4789 in Africa
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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: NCT00917904 |
Recruitment Status :
Completed
First Posted : June 10, 2009
Last Update Posted : December 14, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Acquired Immunodeficiency Syndrome Healthy | Drug: dapivirine Drug: placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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. |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: vehicle placebo gel |
Drug: placebo
dosage form: vaginal gel frequency: once daily duration: 6 weeks |
Experimental: dapivirine gel |
Drug: dapivirine
dosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks |
- Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing. [ Time Frame: Week 0, 1, 2, 4, 6 & 10 ]
- Safety laboratory tests [ Time Frame: enrollment & last day of gel use ]
- Adverse event/serious adverse event reports [ Time Frame: throughout study ]
- Questionnaires concerning acceptability and adherence to daily use of vaginal gel. [ Time Frame: Week 0, 2, 6 & 10 ]
- Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews. [ Time Frame: throughout study ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women 18 to 40 years of age inclusive who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the study
- Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method
- Healthy and self-reported sexually active
- HIV-negative as determined by a HIV rapid test at time of enrollment
- On a stable form of contraception and willing to continue on this stable method of contraception, OR, Have undergone surgical sterilisation at least 3 months prior to enrollment
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses
- Upon pelvic/speculum examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the investigator
- Asymptomatic for genital infections at the time of enrollment
- Willing to refrain from use of vaginal products or objects within 14 days prior to enrollment and for the duration of the study
- Willing to answer acceptability and adherence questionnaires throughout the study
- Willing to refrain from participation in any other research study for the duration of this study
- Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures
Exclusion Criteria:
- Currently pregnant or last pregnancy outcome within 3 months prior to enrolment
- Currently breast-feeding
- Participated in any other research study within 60 days prior to screening
- Previously participated in any HIV vaccine study
- Untreated urogenital infections (either symptomatic or asymptomatic) within 2 weeks prior to enrollment
- Presence of abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction
- Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
- Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences
- Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
- Any serious acute, chronic or progressive disease
- Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives

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): NCT00917904
South Africa | |
Be Part Clinic, Mbekweni | |
Paarl, Eastern Cape, South Africa | |
Madibeng Centre for Research | |
Brits, North West Province, South Africa | |
Desmond Tutu HIV Foundation, Masiphumelele | |
Cape Town, Western Cape, South Africa, 7975 |
Study Director: | Dr Annalene Nel | IPM |
Responsible Party: | Annalene Nel, IPM |
ClinicalTrials.gov Identifier: | NCT00917904 |
Other Study ID Numbers: |
IPM 014B |
First Posted: | June 10, 2009 Key Record Dates |
Last Update Posted: | December 14, 2011 |
Last Verified: | December 2011 |
HIV Infections Acquired Immunodeficiency Syndrome Healthy HIV seronegativity |
HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Infections Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Immune System Diseases Slow Virus Diseases Dapivirine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |