Phase 4
N=270
Trichomonas Vaginalis Recurrence Among HIV+ Women
Trichomonas Infections · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT01018095 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: TV Culture Positive Result — 11; 21 participants — p=.045
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metronidazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Tulane University Health Sciences Center
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TV Culture Positive Result |
8; 19 | =0.03 sig |
| SECONDARY TV Culture Positive Result |
8; 19 | =0.03 sig |
Summary
The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.
Eligibility Criteria
Inclusion Criteria
- Female
- 18 years or older
- HIV-positive
- TV positive by either wet preparation or culture
- ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole
- willing to take metronidazole treatment
Exclusion Criteria
- pregnant
- incarcerated
- previously enrolled
- currently taking disulfiram
- alcoholism or known liver damage
- medical contraindications to metronidazole
- treated with metronidazole within the previous 14 days
- requires treatment for B.V. per Amsel's criteria
Data sourced from ClinicalTrials.gov (NCT01018095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.