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NCT01687218 · ClinicalTrials.gov registry record · Phase 2
Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
A Phase 2 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
NCT01687218 is a Phase 2 study that has completed, run by CONRAD. The registered enrollment target is 195 participants.
The verdict
NCT01687218, a Phase 2 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
Study Summary
MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.
Interventions
- DRUG Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
- DRUG Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
- DRUG Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2015-05-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01687218
The ClinicalTrials.gov registry entry for NCT01687218 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CONRAD, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) is the first listed.
NCT01687218 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01687218 about?
NCT01687218 is a clinical study titled "Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel". MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a his...
What is the current status of trial NCT01687218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2013-09-25. Estimated completion is 2015-05-26.
What interventions are being tested in trial NCT01687218?
The interventions under investigation include: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) (DRUG), Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) (DRUG), Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) (DRUG).
Who is sponsoring clinical trial NCT01687218?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
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