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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Infection; Bacterial Diseases; Other Mycoses
• Intervention / Treatment: Drug: Fluconazole; Drug: Metronizadole

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
• Enrollment: 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Kenya
  • Mombasa, Kenya
    • Ganjoni Municipal Communicable Diseases Control Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: R. Scott McClelland, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (ACTUAL): December 1, 2006
• Study Completion (ACTUAL): December 1, 2006

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (ESTIMATE): September 15, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2010
• Last Update Submitted That Met QC Criteria: March 16, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: HIV-1, sexually transmitted diseases, females, Kenya
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Mycoses; Bacterial Infections; Sexually Transmitted Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: 20486-A; 02-125; 01-0777-A 01 (OTHER: University of Washington Human Subjects Division)