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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 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.

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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.

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

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

45 total trials

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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, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (76% lower). The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.