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NCT01903031 · ClinicalTrials.gov registry record · Phase 2

Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART

A Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target
20
Study locations

NCT01903031: Completed Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

NCT01903031 is a Phase 2 study of HIV-1-infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 84 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01903031, a Phase 2 study of HIV-1-infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target
20
Study locations

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.

Primary Outcome

This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values \< 250 were assigned a value of half the lower limit (ie, 125 pg/mL).

Conditions Studied

HIV-1-infection

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

FieldValue
Enrollment Target 84 participants
Start Date 2014-12-30
Est. Completion 2016-10-10
Phase Phase 2
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

45 total trials

What the finished NCT01903031 record still lists

NCT01903031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (76% lower).

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.

NCT01903031 names 20 study sites across 12 states, led by Other, California, New York.

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.

What interventions are being tested in trial NCT01903031?

The interventions under investigation include: TDF (DRUG), NRTIs (DRUG), Nuvaring (DEVICE), EFV (DRUG), ATV/r (DRUG).

Who is sponsoring clinical trial NCT01903031?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for HIV-1-infection

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01903031's enrollment target sits among peer trials

84 35th of 71 higher than 37 of 71 other HIV-1-infection trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV-1-infection 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

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Related registry views

Source: ClinicalTrials.gov NCT01903031, the US trial registry maintained by the National Library of Medicine. NCT01903031 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.