Last reviewed · How we verify

NCT00170430

Reducing Vaginal Infections in Women at Risk for HIV-1

Completed Phase 3 Last updated 16 March 2010
What this trial tests

Phase 3 trial testing Fluconazole in Bacterial Diseases in 400 participants. Completed in 1 December 2006.

Timeline
1 May 2003
Primary endpoint
1 December 2006
1 December 2006

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment400
Start date1 May 2003
Primary completion1 December 2006
Estimated completion1 December 2006
Sites1 location across Kenya

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

16 and older, female only, with Bacterial Diseases or Other Mycoses. Healthy volunteers can join.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Improvement of vaginal health for Kenyan women at risk for acquisition of human immunodeficiency virus type 1: results of a randomized trial.
    McClelland RS, Richardson BA, Hassan WM, Chohan V, et al · · 2008 · cited 68× · PMID 18444793 · DOI 10.1086/587490

Verify or expand the search:

Other trials of Fluconazole

Trials testing the same drug.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00170430.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing