Trichomonas Vaginalis Recurrence Among HIV+ Women

Phase 4

Completed

• Conditions: HIV Infections; Trichomonas Infections
• Interventions: Drug: Metronidazole

• Registration Number: NCT01018095
• Lead Sponsor: Tulane University Health Sciences Center

Brief 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.

Detailed Description

This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Results First Submitted: 2013-04-11
• Results First Submitted QC: 2013-06-06
• Results First Posted: 2013-07-15
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose	Metronidazole	Metronidazole 2 gm single dose
7 day dose	Metronidazole	Metronidazole 500 mg dose x 7 days

Primary Outcome Measures

Name	Time	Method
TV Culture Positive Result	test-of-cure visit at 6-12 days post-treatment completion	At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.

Secondary Outcome Measures

Name	Time	Method
TV Culture Positive Result	3 months post-enrollment	Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.

Trial Locations

Locations (5)

HIV Outpatient Clinic; 🇺🇸 New Orleans, Louisiana, United States

NOAIDS; 🇺🇸 New Orleans, Louisiana, United States

Crossroads Clinic; 🇺🇸 Jackson, Mississippi, United States

Thomas St Clinic; 🇺🇸 Houston, Texas, United States

Northwest Clinic; 🇺🇸 Houston, Texas, United States