Trial · NCT01018095
Trichomonas Vaginalis Recurrence Among HIV+ Women
NCT01018095, Phase 4, Completed, Tulane University Health Sciences Center; results first posted 2013-07-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trichomonas Vaginalis Recurrence Among HIV+ Women. Trials, record NCT01018095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01018095
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trichomonas Vaginalis Recurrence Among HIV+ Women
- NCT number
- NCT01018095
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 270 participants, actual
- Lead sponsor
- Tulane University Health Sciences Center
- Conditions
- Trichomonas Infections, HIV Infections
- Interventions
- Metronidazole
- First posted
- 2009-11-23
- Last updated
- 2016-12-20
- Results first posted
- 2013-07-15
- 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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TV Culture Positive Result | test-of-cure visit at 6-12 days post-treatment completion | 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. |
| Secondary | TV Culture Positive Result | 3 months post-enrollment | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | TV Culture Positive Result | test-of-cure visit at 6-12 days post-treatment completion | Participants who returned for their test of cure visit | participants | NUMBER |
| SECONDARY | TV Culture Positive Result | 3 months post-enrollment | Participants who returned for their 3 mo follow up visit | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| TV Culture Positive Result | 7 Day Dose | 11 | participants | ||
| TV Culture Positive Result | Single Dose | 21 | participants | ||
| TV Culture Positive Result | 7 Day Dose | 8 | 7.3 to 14.7 | participants | |
| TV Culture Positive Result | Single Dose | 19 | 19.3 to 28.9 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 7 Day Dose | 135 | |
| Overall Study | STARTED | Single Dose | 135 | |
| Overall Study | COMPLETED | 7 Day Dose | 79 | |
| Overall Study | COMPLETED | Single Dose | 73 | |
| Overall Study | NOT COMPLETED | 7 Day Dose | 56 | |
| Overall Study | NOT COMPLETED | Single Dose | 62 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 7 Day Dose | ||
| Total, all-cause mortality | Single Dose | ||
| Total, other adverse events | 7 Day Dose | 0 | 135 |
| Total, other adverse events | Single Dose | 0 | 135 |
| Total, serious adverse events | 7 Day Dose | 0 | 135 |
| Total, serious adverse events | Single Dose | 0 | 135 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U19AI061972 | Gulf South STI/Topical Microbicide Cooperative Research Center | MARTIN, DAVID H. | LSU HEALTH SCIENCES CENTER | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2004 to 2009 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 7 Day Dose vs Single Dose: TV Culture Positive Result | Trial comparisons |
| 7 Day Dose vs Single Dose: TV Culture Positive Result | Trial comparisons |
| 7 Day Dose vs Single Dose: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01018095
GET https://conductscience.org/api/trials/v1/NCT01018095/registered