Trial Outcomes & Findings for Trichomonas Vaginalis Recurrence Among HIV+ Women (NCT NCT01018095)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

270 participants

Primary outcome timeframe

test-of-cure visit at 6-12 days post-treatment completion

Results posted on

2016-12-20

Participant Flow

HIV-infected women undergoing a routine gynecological examination performed by a clinic health care provider between May 1, 2006 and July 17, 2009 were tested for Trichomonas Vaginalis (TV) by culture as standard of care practice in selected public HIV outpatient clinics in New Orleans, Louisiana; Houston, Texas; and Jackson, Mississippi.

Participant milestones

Participant milestones
Measure	7 Day Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose	Single Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
Overall Study STARTED	135	135
Overall Study COMPLETED	79	73
Overall Study NOT COMPLETED	56	62

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trichomonas Vaginalis Recurrence Among HIV+ Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	7 Day Dose n=135 Participants Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose	Single Dose n=135 Participants Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose	Total n=270 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	135 Participants n=5 Participants	134 Participants n=7 Participants	269 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	39.5 years STANDARD_DEVIATION 9.3 • n=5 Participants	40.7 years STANDARD_DEVIATION 9.4 • n=7 Participants	40.1 years STANDARD_DEVIATION 9.4 • n=5 Participants
Gender Female	135 Participants n=5 Participants	135 Participants n=7 Participants	270 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	135 participants n=5 Participants	135 participants n=7 Participants	270 participants n=5 Participants

PRIMARY outcome

Timeframe: test-of-cure visit at 6-12 days post-treatment completion

Population: Participants who returned for their test of cure visit

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.

Outcome measures

Outcome measures
Measure	7 Day Dose n=130 Participants Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose	Single Dose n=125 Participants Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
TV Culture Positive Result	11 participants	21 participants

SECONDARY outcome

Timeframe: 3 months post-enrollment

Population: Participants who returned for their 3 mo follow up visit

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.

Outcome measures

Outcome measures
Measure	7 Day Dose n=73 Participants Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose	Single Dose n=79 Participants Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
TV Culture Positive Result	8 participants Interval 7.3 to 14.7	19 participants Interval 19.3 to 28.9

Adverse Events

7 Day Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patricia Kissinger, PhD

Tulane University

Phone: 5049887320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place