Early ART to Limit Infection and Establishment of Reservoir

PHASE2CompletedINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

January 24, 2017

Primary Completion Date

December 2, 2020

Study Completion Date

April 16, 2025

Conditions
HIV-1 Infection
Interventions
DRUG

elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy

Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.

Trial Locations (30)

18

Barranco CRS, Lima

10010

7804 Weill Cornell Chelsea CRS, New York

10032

Columbia Physicians and Surgeons CRS (30329), New York

10330

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

15213

Pittsburgh CRS (1001), Pittsburgh

19104

6201 Penn Therapeutics CRS, Philadelphia

20009

Whitman Walker Health CRS (31791), Washington D.C.

21045

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

27401

Greensboro CRS (3203), Greensboro

27516

3201 Chapel Hill CRS, Chapel Hill

30308

The Ponce de Leon Center CRS (5802), Atlanta

35294

31788 Alabama CRS, Birmingham

43210

The Ohio State Univ. AIDS CRS (2301), Columbus

45267

Univ. of Cincinnati CRS (2401), Cincinnati

60611

Northwestern University CRS (2701), Chicago

60612

Rush Univ. Med. Ctr. ACTG CRS (2702), Chicago

63110

Washington University CRS (2101), St Louis

75208

31443 Trinity Health and Wellness Center CRS, Dallas

77030

31473 Houston AIDS Research Team (HART) CRS, Houston

90502

Harbor-UCLA Med. Ctr. CRS (603), Torrance

92103

Ucsd, Avrc Crs (701), San Diego

98104

University of Washington AIDS CRS (1401), Seattle

9043010

Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre

02114

Massachusetts General Hospital ACTG CRS (101), Boston

02115

Brigham and Women's Hosp. ACTG CRS (107), Boston

07103

31786 New Jersey Medical School Clinical Research Center CRS, Newark

02906

The Miriam Hosp. ACTG CRS (2951), Providence

Unknown

Malawi CRS (12001), Lilongwe

San Miguel CRS (11302), San Isidro

Milton Park CRS (30313), Harare

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

NCT02859558 - Early ART to Limit Infection and Establishment of Reservoir | Biotech Hunter | Biotech Hunter