- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140764
Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi
August 9, 2011 updated by: Johns Hopkins Bloomberg School of Public Health
The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected.
The study will also determine the effect of these vaginal gels on genitourinary symptoms.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This is a phase 3, randomized, double masked, two arms study conducted in Malawi, Southeast Africa.
The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age.
Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment.
Women receive assigned product every three months for one year.
Study Type
Interventional
Phase
- Phase 3
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 55 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Nonpregnant HIV-Uninfected HIV-Infected
Exclusion Criteria:
Pregnant
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Prevalence of bacterial vaginosis
|
Reported genitourinary symptoms
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Taha E Taha, MD PhD, Johns Hopkins Bloomberg School of Public Health
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.
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
January 1, 2003
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
August 10, 2011
Last Update Submitted That Met QC Criteria
August 9, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METRO STUDY
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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