- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00917904
An Expanded Safety Study of Dapivirine Gel 4789 in Africa
December 13, 2011 updated by: International Partnership for Microbicides, Inc.
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.
The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Eastern Cape
-
Paarl, Eastern Cape, South Africa
- Be Part Clinic, Mbekweni
-
-
North West Province
-
Brits, North West Province, South Africa
- Madibeng Centre for Research
-
-
Western Cape
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Cape Town, Western Cape, South Africa, 7975
- Desmond Tutu HIV Foundation, Masiphumelele
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: vehicle placebo gel
|
dosage form: vaginal gel frequency: once daily duration: 6 weeks |
Experimental: dapivirine gel
|
dosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing.
Time Frame: Week 0, 1, 2, 4, 6 & 10
|
Week 0, 1, 2, 4, 6 & 10
|
Safety laboratory tests
Time Frame: enrollment & last day of gel use
|
enrollment & last day of gel use
|
Adverse event/serious adverse event reports
Time Frame: throughout study
|
throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Questionnaires concerning acceptability and adherence to daily use of vaginal gel.
Time Frame: Week 0, 2, 6 & 10
|
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
|
throughout study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dr Annalene Nel, IPM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
June 8, 2009
First Submitted That Met QC Criteria
June 8, 2009
First Posted (Estimate)
June 10, 2009
Study Record Updates
Last Update Posted (Estimate)
December 14, 2011
Last Update Submitted That Met QC Criteria
December 13, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dapivirine
Other Study ID Numbers
- IPM 014B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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