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NCT00170430
Reducing Vaginal Infections in Women at Risk for HIV-1
Phase 3 trial testing Fluconazole in Bacterial Diseases in 400 participants. Completed in 1 December 2006.
1 December 2006
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 400 |
| Start date | 1 May 2003 |
| Primary completion | 1 December 2006 |
| Estimated completion | 1 December 2006 |
| Sites | 1 location across Kenya |
Drugs / interventions tested
- Fluconazole (fluconazole) — full drug profile →
- Metronizadole — full drug profile →
Conditions studied
- Bacterial Diseases — all drugs for Bacterial Diseases →
- Other Mycoses — all drugs for Other Mycoses →
- Sexually Transmitted Infection — all drugs for Sexually Transmitted Infection →
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):
-
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:
- PubMed search for NCT00170430
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00170430 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Washington
- Last refreshed: 16 March 2010
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.
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