Trichomonas Vaginalis Recurrence Among HIV+ Women

HIV Infections Clinical Trial

Official title:

Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018095
• Other study ID #: 543793
• Secondary ID: U19AI061972
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2009
• Last updated: December 16, 2016
• Start date: May 2005
• Est. completion date: August 2009

Study information

• Verified date: December 2016
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Trichomonas Infections

Intervention

Drug:
• Metronidazole
2 gm single dose versus 7 day 500 mg BID dose

Locations

Country	Name	City	State
United States	Northwest Clinic	Houston	Texas
United States	Thomas St Clinic	Houston	Texas
United States	Crossroads Clinic	Jackson	Mississippi
United States	HIV Outpatient Clinic	New Orleans	Louisiana
United States	NOAIDS	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University Health Sciences Center	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TV Culture Positive Result	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.	test-of-cure visit at 6-12 days post-treatment completion	No
Secondary	TV Culture Positive Result	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.	3 months post-enrollment	No