A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

PHASE4CompletedINTERVENTIONAL
Enrollment

545

Participants

Timeline

Start Date

February 22, 2013

Primary Completion Date

November 23, 2016

Study Completion Date

December 31, 2018

Conditions
HIV-1 Infection
Interventions
DRUG

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 \[200 mg per day\])

DRUG

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.

DRUG

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.

DRUG

Raltegravir

Participants were administered Raltegravir orally as one 400 mg tablet twice daily (800 mg per day), with or without food

DRUG

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.

DRUG

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).

OTHER

SOC adherence versus SOC+CPI adherence

"* not participating in the adherence randomization; OR~* randomized to SOC adherence; OR~* randomized to SOC+CPI adherence."

Trial Locations (19)

2193

University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101), Johannesburg

7505

Family Clinical Research Unit (FAM-CUR) CRS (8950), Cape Town

10330

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

21045

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

30100

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601), Eldoret

40100

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

50200

31784 Chiang Mai University HIV Treatment CRS, Chiang Mai

411001

BJ Medical College CRS (31441), Pune

600113

Chennai Antiviral Research and Treatment (CART) CRS (11701), Chennai

9043010

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

HT-6110

Les Centres GHESKIO CRS (30022), Port-au-Prince

Unknown

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

18 PE

Barranco CRS (11301), Lima

4013 SF

Durban Adult HIV CRS (11201), Durban

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

AbbVie

INDUSTRY

collaborator

Gilead Sciences

INDUSTRY

collaborator

Janssen Pharmaceuticals

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Dimagi Inc.

INDUSTRY

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK