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Trichomonas Vaginalis Recurrence Among HIV+ Women

NCT ID: NCT01018095

Last Updated: 2016-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Trichomonas Infections HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Single dose

Metronidazole 2 gm single dose

Group Type ACTIVE_COMPARATOR

Metronidazole

Intervention Type DRUG

2 gm single dose versus 7 day 500 mg BID dose

7 day dose

Metronidazole 500 mg dose x 7 days

Group Type ACTIVE_COMPARATOR

Metronidazole

Intervention Type DRUG

2 gm single dose versus 7 day 500 mg BID dose

Interventions

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Metronidazole

2 gm single dose versus 7 day 500 mg BID dose

Intervention Type DRUG

Other Intervention Names

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Flagyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Tulane University Health Sciences Center

OTHER

Sponsor Role lead

Responsible Party

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Patricia Kissinger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Kissinger, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

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HIV Outpatient Clinic

New Orleans, Louisiana, United States

Site Status

NOAIDS

New Orleans, Louisiana, United States

Site Status

Crossroads Clinic

Jackson, Mississippi, United States

Site Status

Thomas St Clinic

Houston, Texas, United States

Site Status

Northwest Clinic

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30297322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21423852 (View on PubMed)

Other Identifiers

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U19AI061972

Identifier Type: NIH

Identifier Source: secondary_id

View Link

543793

Identifier Type: -

Identifier Source: org_study_id