Trichomonas Vaginalis Recurrence Among HIV+ Women

Tulane University Health Sciences Center

Status and phase: Completed; Phase 4

Conditions: Trichomonas Infections; HIV Infections

Treatments: Drug: Metronidazole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01018095

543793

U19AI061972 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

Single dose

Active Comparator group

Description:

Metronidazole 2 gm single dose

Treatment:

Drug: Metronidazole

7 day dose

Active Comparator group

Description:

Metronidazole 500 mg dose x 7 days

Treatment:

Drug: Metronidazole