Clinical trial NCT01018095: Trichomonas Vaginalis Recurrence Among HIV+ Women
Official title: Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trichomonas Infections
HIV Infections
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-11-23
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: TV Culture Positive Result
timeFrame: test-of-cure visit at 6-12 days post-treatment completion
Secondary outcomes:
measure: TV Culture Positive Result
timeFrame: 3 months post-enrollment
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: HIV Outpatient Clinic
state: Louisiana
city: New Orleans
country: United States
facility: NOAIDS
state: Louisiana
city: Jackson
country: United States
facility: Crossroads Clinic
state: Mississippi
city: Houston
country: United States
facility: Thomas St Clinic
state: Texas
city: Houston
country: United States
facility: Northwest Clinic
state: Texas
Study officials:
affiliation: Tulane University
name: Patricia Kissinger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kissinger P, Muzny CA, Mena LA, Lillis RA, Schwebke JR, Beauchamps L, Taylor SN, Schmidt N, Myers L, Augostini P, Secor WE, Bradic M, Carlton JM, Martin DH. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Nov;18(11):1251-1259. doi: 10.1016/S1473-3099(18)30423-7. Epub 2018 Oct 5.
citation: Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, Schmidt N, Rosenthal SL, Myers L, Martin DH. A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955.