Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02431273 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women
A Early Phase 1 study, sponsored by Auritec Pharmaceuticals.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT02431273: Completed Early Phase 1 study, sponsored by Auritec Pharmaceuticals.
NCT02431273 is a Early Phase 1 study that has completed, run by Auritec Pharmaceuticals. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431273, a Early Phase 1 study, has completed, sponsored by Auritec Pharmaceuticals.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR). TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc
Primary Outcome
Number of Adverse Events (AEs) was recorded. Safety parameters were monitored for each IVR combination and the grading scale for each parameter followed the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014 (Grade 1 = mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life-
Interventions
- DRUG TDF IVR
- DRUG TDF-FTC IVR
- DRUG TDF-FTC-MVC IVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-12 |
| Phase | Early Phase 1 |
What the finished NCT02431273 record still lists
NCT02431273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which TDF IVR is the first listed.
NCT02431273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02431273 about?
NCT02431273 is a clinical study titled "Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women". This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ...
What is the current status of trial NCT02431273?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2015-06. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02431273?
The interventions under investigation include: TDF IVR (DRUG), TDF-FTC IVR (DRUG), TDF-FTC-MVC IVR (DRUG).
Who is sponsoring clinical trial NCT02431273?
This trial is sponsored by Auritec Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02431273's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
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