Reducing Vaginal Infections in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170430
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 18, 2010
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Diseases Other Mycoses Sexually Transmitted Infection Drug: Fluconazole Drug: Metronizadole Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Reducing Vaginal Infections in Women at Risk for HIV-1
Study Start Date : May 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170430

Ganjoni Municipal Communicable Diseases Control Centre
Mombasa, Kenya
Sponsors and Collaborators
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: R. Scott McClelland, MD, MPH University of Washington

Responsible Party: Dr. Scott McClelland, University of Washington Identifier: NCT00170430     History of Changes
Other Study ID Numbers: 20486-A
01-0777-A 01 ( Other Identifier: University of Washington Human Subjects Division )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 18, 2010
Last Verified: March 2010

Keywords provided by University of Washington:
HIV-1, sexually transmitted diseases, females, Kenya

Additional relevant MeSH terms:
Communicable Diseases
Sexually Transmitted Diseases
Bacterial Infections
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors