- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00303576
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
July 28, 2006 updated by: International Partnership for Microbicides, Inc.
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.
Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites.
Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel.
The volunteers will receive investigational product for a total of 42 days.
Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
112
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
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Kigali, Rwanda
- Projet Ubuzima
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Bloemfontein, South Africa
- Farmovs-Parexel
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Johannesburg
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Yeoville, Johannesburg, South Africa
- Reproductive Health Research Unit - Sheshisani IPM Clinic
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Moshi, Tanzania
- Kilimanjaro Reproductive Health Program
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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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
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: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Local and systemic safety and tolerability.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Zeda Rosenberg, ScD, IPM
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
October 1, 2005
Study Completion
July 1, 2006
Study Registration Dates
First Submitted
March 15, 2006
First Submitted That Met QC Criteria
March 15, 2006
First Posted (Estimate)
March 17, 2006
Study Record Updates
Last Update Posted (Estimate)
July 31, 2006
Last Update Submitted That Met QC Criteria
July 28, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
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
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dapivirine
Other Study ID Numbers
- IPM003
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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