Reducing Vaginal Infections in Women

NCT ID: NCT00170430

Last Updated: 2010-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2006-12-31

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.

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.

Conditions

Bacterial Diseases; Other Mycoses; Sexually Transmitted Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Fluconazole

Intervention Type: DRUG

Metronizadole

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

R. Scott McClelland, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Ganjoni Municipal Communicable Diseases Control Centre

Mombasa, , Kenya

Countries

Kenya

Other Identifiers

01-0777-A 01

Identifier Type: OTHER

Identifier Source: secondary_id

02-125

Identifier Type: -

Identifier Source: secondary_id

20486-A

Identifier Type: -

Identifier Source: org_study_id