NCT01903031 - Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 30, 2014

Primary Completion Date

October 3, 2016

Study Completion Date

October 10, 2016

Conditions

HIV-1 Infection

Interventions

DEVICE

Nuvaring

NuvaRing is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate, is latex free, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing has an outer diameter of 54 mm and a cross-sectional diameter of 4mm. Once NuvaRing is inserted into the vagina, the ring should remain in place (not be removed) continuously for 3 weeks (21 days). After being in place for the first 21 days of the study, the ring may be removed after the day 21 study visit evaluations have been completed.

DRUG

EFV

Participants received EFV 600 mg daily with two or more NRTIs

DRUG

ATV/r

Participants received ATV/r 300 mg/ 100 mg daily with tenofovir and one or more additional NRTIs

DRUG

TDF

Participants received 300 mg of tenofovir in Arm C

DRUG

NRTIs

Participants received two or more NRTIs in Arm B and one or more NRTIs in Arm C

Trial Locations (21)

2038

Shandukani Research CRS (8051), Johannesburg

10032

Columbia Physicians and Surgeons CRS (30329), New York

10330

31802 Thai Red Cross AIDS Research Center Treatment (TRC-ARC Treatment) CRS, Bangkok

10461

Jacobi Medical Center Bronx, The Bronx

21045

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro

32209

University of Florida Jacksonville (5051), Jacksonville

35294

31788 Alabama CRS, Birmingham

40100

Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS (31460), Kisumu

50200

31784 Chiang Mai University HIV Treatment CRS, Chiang Mai

60612

Rush University Cook County Hospital Chicago NICHD CRS (5083), Chicago

80045

University of Colorado Denver NICHD CRS (5052), Aurora

90033

University of Southern California LA (5048), Los Angeles

90095-1752

David Geffen School of Medicine at UCLA NICHD CRS (5112), Los Angeles

07103

31786 New Jersey Medical School Clinical Research Center CRS, Newark

02906

The Miriam Hosp. ACTG CRS (2951), Providence

Unknown

Gaborone Prevention/Treatment Trials CRS (12701), Gaborone

Investigaciones Medicas en Salud (INMENSA) (11302), San Isidro

18 PE

Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima

00935

Puerto Rico-AIDS CRS (5401), San Juan

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS (6601), San Juan

00936

San Juan Hospital PR NICHD CRS (5031), San Juan

All Listed Sponsors

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK