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Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART
NCT01903031 · View on ClinicalTrials.gov ↗
Study Summary
This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. The investigators did not know whether the NuvaRing and ARVs interact when they are used together, so this study looked to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study also included HIV-infected women who were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs. Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, the investigators wanted to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of the female genital tract, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.
Conditions Studied
Interventions
- DRUG TDF
- DRUG NRTIs
- DEVICE Nuvaring
- DRUG EFV
- DRUG ATV/r
Study Locations (20)
Other
- Gaborone Prevention/Treatment Trials CRS (12701) — Gaborone
- Instituto de Pesquisa Clinica Evandro Chagas (12101) — Rio de Janeiro
- Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS (31460) — Kisumu
- Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301) — Lima
- Puerto Rico-AIDS CRS (5401) — San Juan
- University of Puerto Rico Pediatric HIV/AIDS Research Program CRS (6601) — San Juan
- San Juan Hospital PR NICHD CRS (5031) — San Juan
California
- University of Southern California LA (5048) — Los Angeles
- David Geffen School of Medicine at UCLA NICHD CRS (5112) — Los Angeles
New York
- Columbia Physicians and Surgeons CRS (30329) — New York
- Jacobi Medical Center Bronx — The Bronx
Alabama
- 31788 Alabama CRS — Birmingham
Colorado
- University of Colorado Denver NICHD CRS (5052) — Aurora
Florida
- University of Florida Jacksonville (5051) — Jacksonville
Illinois
- Rush University Cook County Hospital Chicago NICHD CRS (5083) — Chicago
New Jersey
- 31786 New Jersey Medical School Clinical Research Center CRS — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2014-12-30 |
| Est. Completion | 2016-10-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01903031
The ClinicalTrials.gov registry entry for NCT01903031 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV-1 Infection appearing as the primary indexed condition, and to 5 interventions — of which TDF is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01903031 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01903031 about?
NCT01903031 is a clinical study titled "Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART". This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARV...
What is the current status of trial NCT01903031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2014-12-30. Estimated completion is 2016-10-10.
What conditions does trial NCT01903031 study?
This clinical trial studies the following conditions: HIV-1 Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01903031?
The interventions under investigation include: TDF (DRUG), NRTIs (DRUG), Nuvaring (DEVICE), EFV (DRUG), ATV/r (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01903031?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01903031 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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