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NCT01687205 · ClinicalTrials.gov registry record · Phase 1
Coital Pharmacokinetics/Pharmacodynamics (PK/PD) of Tenofovir Gel
A Phase 1 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01687205 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 31 participants.
The verdict
NCT01687205, a Phase 1 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Study Objectives: * To assess the impact of coitus (and semen) on the pharmacokinetics of tenofovir 1% gel in female genital tract secretions, vaginal and cervical tissue and rectal tract secretions * To assess the impact of coitus (and semen) on pharmacodynamics of luminal drug by measuring the anti-HIV-1 activity in CVL samples Study Summary: MTN-011 will enroll heterosexual monogamous, sexually active couples, in which both partners are healthy and HIV-negative. The female participants must be between the ages of 21-46 (inclusive) and currently using effective non-barrier contraception. Male participants must be 21 years of age or older. This Phase 1 expanded safety study will assess tenofovir PK in the genital tract secretions (CVL), rectal (rectal sponge) and both intracellular and extracellular tissue compartments (vaginal biopsy) in the absence of, or following coitus. Pharmacodynamics (antiviral activity) will also be assessed in CVL. MTN-011 will study the timing in which coitus might have the greatest impact on these variables, which is when gel is applied shortly prior to coitus in the absence of a drug reservoir. MTN-011 will examine PK/PD in response to a single dose of 1% tenofovir gel applied shortly before sex and compare to PK/PD assessments following a single gel application without sex. Additionally, data obtained from a visit in which participants do not dose with gel and do not have sex will serve as an additional control for the pharmacodynamic (PD) studies of the antiviral activity in CVL. If tenofovir retains its antiviral activity following sex, then the anti-HIV activity in CVL collected at the visit in which female participants dose with gel and have sex should be comparable to that of CVL collected at the visit in which females dose with gel and then do not engage in intercourse and significantly greater than the endogenous anti-HIV activity in CVL obtained at the visit in which participants do not dose with gel but do have sex and th
Interventions
- DRUG 1% Tenofovir Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01687205
The ClinicalTrials.gov registry entry for NCT01687205 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 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 1 intervention - of which 1% Tenofovir Gel is the first listed.
NCT01687205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01687205 about?
NCT01687205 is a clinical study titled "Coital Pharmacokinetics/Pharmacodynamics (PK/PD) of Tenofovir Gel". Study Objectives: * To assess the impact of coitus (and semen) on the pharmacokinetics of tenofovir 1% gel in female genital tract secretions, vaginal and cervical tissue and rectal tract secretions * To assess the impact of coitus (and semen) on pharmacodynamics of luminal drug by measuring the an...
What is the current status of trial NCT01687205?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2012-11. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01687205?
The interventions under investigation include: 1% Tenofovir Gel (DRUG).
Who is sponsoring clinical trial NCT01687205?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
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