545
Participants
Start Date
February 22, 2013
Primary Completion Date
November 23, 2016
Study Completion Date
December 31, 2018
Darunavir
Participants were administered darunavir orally as one 600 mg tablet twice a day (1200 mg per day) with food (taken with Ritonavir 100 mg twice a day \[200 mg per day\])
Etravirine
Patients were administered Etravirine orally as two 100 mg tablets or one 200 mg tablet twice a day (400 mg per day) following a meal.
Emtricitabine/tenofovir disoproxil fumarate
Patients were administered FTC/TDF orally as one fixed dose combination tablet (FTC 200 mg/TDF 300 mg) once daily, with or without food.
Raltegravir
Participants were administered Raltegravir orally as one 400 mg tablet twice daily (800 mg per day), with or without food
Second line ART regimens - based on a boosted protease inhibitor (bPI) plus two nucleoside analogues (NRTIs)
LPV/r and ATV/r were the preferred bPIs for second-line ART. TDF + (3TC or FTC) or AZT + 3TC were the most frequent NRTI backbones. Cohort A did not include any of the new drugs; therefore, it is distinct from Cohorts B, C, and D.
Study provided drugs according to patient resistance profile (DRV, ETR, RTV, FTC/TDF) + any in country available drug as applicable & available
For Cohort D, in many situations a participant received the same regimen that patients are getting in Cohorts B and C if that was the best combination that can be obtained according to his/her resistance profile and drug availability (as for many countries there were no further drug options beyond the available study drugs).
SOC adherence versus SOC+CPI adherence
"* not participating in the adherence randomization; OR~* randomized to SOC adherence; OR~* randomized to SOC+CPI adherence."
University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101), Johannesburg
Family Clinical Research Unit (FAM-CUR) CRS (8950), Cape Town
31802 Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Bangkok
Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro
AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601), Eldoret
Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS (31460), Kisumu
31784 Chiang Mai University HIV Treatment CRS, Chiang Mai
BJ Medical College CRS (31441), Pune
Chennai Antiviral Research and Treatment (CART) CRS (11701), Chennai
Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre
Les Centres GHESKIO CRS (30022), Port-au-Prince
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince
Malawi CRS (12001), Lilongwe
San Miguel CRS (11302), San Miguel
Soweto ACTG CRS (12301), Johannesburg
JCRC CRS, Kampala
UZ-Parirenyatwa CRS (30313), Harare
Barranco CRS (11301), Lima
Durban Adult HIV CRS (11201), Durban
Collaborators (3)
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
AbbVie
INDUSTRY
Gilead Sciences
INDUSTRY
Janssen Pharmaceuticals
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Dimagi Inc.
INDUSTRY
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK