An Expanded Safety Study of Dapivirine Gel 4789 in Africa
This study has been completed.
Sponsor:
International Partnership for Microbicides, Inc.
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00917904
First received: June 8, 2009
Last updated: December 13, 2011
Last verified: December 2011
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Purpose
The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Acquired Immunodeficiency Syndrome Healthy |
Drug: dapivirine Drug: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
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.:
Primary Outcome Measures:
- Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing. [ Time Frame: Week 0, 1, 2, 4, 6 & 10 ] [ Designated as safety issue: Yes ]
- Safety laboratory tests [ Time Frame: enrollment & last day of gel use ] [ Designated as safety issue: Yes ]
- Adverse event/serious adverse event reports [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Questionnaires concerning acceptability and adherence to daily use of vaginal gel. [ Time Frame: Week 0, 2, 6 & 10 ] [ Designated as safety issue: No ]
- Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Detailed Description:
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 |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917904
Locations
| 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 | |
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
| Study Director: | Dr Annalene Nel | IPM |
More Information
Additional Information:
No publications provided
| Responsible Party: | Annalene Nel, IPM |
| ClinicalTrials.gov Identifier: | NCT00917904 History of Changes |
| Other Study ID Numbers: | IPM 014B |
| Study First Received: | June 8, 2009 |
| Last Updated: | December 13, 2011 |
| Health Authority: | South Africa: Medicines Control Council |
Keywords provided by International Partnership for Microbicides, Inc.:
|
HIV Infections Acquired Immunodeficiency Syndrome Healthy HIV seronegativity |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013