NCT01018095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2005

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

July 15, 2013

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

4.2 years

First QC Date

November 20, 2009

Results QC Date

April 11, 2013

Last Update Submit

December 16, 2016

Conditions

Trichomonas InfectionsHIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • TV Culture Positive Result

    3 months post-enrollment

Study Arms (2)

Single dose

ACTIVE COMPARATOR

Metronidazole 2 gm single dose

Drug: Metronidazole

7 day dose

ACTIVE COMPARATOR

Metronidazole 500 mg dose x 7 days

Drug: Metronidazole

Interventions

MetronidazoleDRUG

2 gm single dose versus 7 day 500 mg BID dose

Also known as: Flagyl
7 day doseSingle dose

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

HIV Outpatient Clinic

New Orleans, Louisiana, 70112, United States

Location

NOAIDS

New Orleans, Louisiana, 70119, United States

Location

Crossroads Clinic

Jackson, Mississippi, 39216, United States

Location

Thomas St Clinic

Houston, Texas, 77009, United States

Location

Northwest Clinic

Houston, Texas, 77040, United States

Location

Related Publications (2)

  • 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.

    PMID: 30297322DERIVED

  • 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.

    PMID: 21423852DERIVED

MeSH Terms

Conditions

Trichomonas InfectionsHIV Infections

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Generalizability is always a concern in clinical trials, however our findings are likely generalizable to the majority of HIV-infected women in the U.S. though studies in Caucasian and Hispanic women are needed.

Results Point of Contact

Title
Patricia Kissinger, PhD
Organization
Tulane University
kissing@tulane.edu
5049887320

Study Officials

  • Patricia Kissinger, Ph.D.

    Tulane University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

May 1, 2005

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

December 20, 2016

Results First Posted

July 15, 2013

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(5)