Reducing Vaginal Infections in Women - Full Text View

Purpose

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	Intervention	Phase
Bacterial Diseases Other Mycoses Sexually Transmitted Infection	Drug: Fluconazole Drug: Metronizadole	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Reducing Vaginal Infections in Women at Risk for HIV-1

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

Drug Information available for: Fluconazole

U.S. FDA Resources

Further study details as provided by University of Washington:


Estimated Enrollment:	400
Study Start Date:	May 2003
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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.

Eligibility


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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170430

Locations


Kenya
Ganjoni Municipal Communicable Diseases Control Centre
Mombasa, Kenya

Sponsors and Collaborators

University of Washington

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Principal Investigator:	R. Scott McClelland, MD, MPH	University of Washington

More Information


Responsible Party:	Dr. Scott McClelland, University of Washington
ClinicalTrials.gov Identifier:	NCT00170430 History of Changes
Other Study ID Numbers:	20486-A 01-0777-A 01 02-125
Study First Received:	September 9, 2005
Last Updated:	March 16, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:


HIV-1, sexually transmitted diseases, females, Kenya

Additional relevant MeSH terms:


Infection Communicable Diseases Mycoses Sexually Transmitted Diseases Bacterial Infections Virus Diseases Genital Diseases, Male Genital Diseases, Female Fluconazole 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

ClinicalTrials.gov processed this record on September 28, 2016