Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01330199 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT01330199: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01330199 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01330199, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal tissues. This will be accomplished by determining the pharmacokinetic disposition and dose proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal tissue.
Primary Outcome
To determine if antiretroviral mucosal fluid and tissue concentrations change proportionally with a change in antiretroviral dose.
Interventions
- OTHER Pharmacokinetic Sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01330199 record still lists
NCT01330199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which Pharmacokinetic Sampling is the first listed.
NCT01330199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01330199 about?
NCT01330199 is a clinical study titled "Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions". The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal tissues. This will be accomplished by determining the pharmacokinetic disposition and dose proportionality of four ant...
What is the current status of trial NCT01330199?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-02. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01330199?
The interventions under investigation include: Pharmacokinetic Sampling (OTHER).
Who is sponsoring clinical trial NCT01330199?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01330199's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02704858 · 49 participants · Phase 1
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
- NCT03516708 · 49 participants · Phase 1
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- NCT03692429 · 49 participants · Phase 1
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
- NCT04329494 · 49 participants · Phase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia