Reducing Vaginal Infections in Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00170430
First received: September 9, 2005
Last updated: March 16, 2010
Last verified: March 2010

September 9, 2005
March 16, 2010
May 2003
December 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00170430 on ClinicalTrials.gov Archive Site
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Reducing Vaginal Infections in Women
Reducing Vaginal Infections in Women at Risk for HIV-1

The purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douching, bathing, and sexual practices can influence the risk of vaginal infections. Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16 and older, living in Mombasa. Study procedures will include sexual behavior questions, physical examinations including pelvic exams, testing of vaginal and cervical secretions for STDs, urine collection and blood samples. Participants will receive 2 different types of pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no medication). Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals.

Prospective studies in Africa have demonstrated that vaginal infections are associated with a significant increase in a woman's risk of infection with HIV-1. Further clinical and epidemiological research is needed to evaluate strategies for prevention and treatment of vaginal infections as a means of reducing HIV-1 acquisition. Developing a vaginal health intervention to reduce the risk of HIV-1 infection is a particularly important goal in sub-Saharan Africa, where female controlled strategies for reducing the risk of HIV-1 transmission may be an important means of decreasing the spread of the epidemic. This study will evaluate the efficacy of a regimen for reducing the rate of vaginal infections. The study is a double blind, randomized, controlled trial of monthly treatment with single-dose metronidazole and fluconazole as a means of decreasing vaginal infections and promoting normal vaginal flora in HIV-1 seronegative female sex workers (FSWs) in Mombasa, Kenya. Participants will be recruited from an existing cohort of HIV-1 seronegative FSWs followed at a municipal sexually transmitted disease (STD) clinic in Mombassa, Kenya, since February 1993. Participants will be randomized to treatment with metronidazole 2 grams plus fluconazole 150 mg once a month or placebo. All patients will be asked to return for follow-up after 1 month. All women in the study will be treated as indicated for symptomatic vaginal infections, other genital track infections and followed until they have completed 12 monthly follow-up visits.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Bacterial Diseases
  • Other Mycoses
  • Sexually Transmitted Infection
  • Drug: Fluconazole
  • Drug: Metronizadole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who do not currently have symptoms of vaginal itching or discharge. Women with these symptoms may be treated and enrolled at a subsequent monthly visit when they are asymptomatic.
  • Those who are currently menstruating may be enrolled after the completion of menses.

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • History of adverse reactions to the study medications
  • Alcoholism or inability to abstain from alcohol for 48 hours following treatment
  • Women who do not anticipate living in Mombasa for a year following enrollment.
Female
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00170430
20486-A, 01-0777-A 01, 02-125
Not Provided
Dr. Scott McClelland, University of Washington
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: R. Scott McClelland, MD, MPH University of Washington
University of Washington
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP