REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

PHASE4CompletedINTERVENTIONAL
Enrollment

851

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

January 31, 2015

Study Completion Date

April 30, 2016

Conditions
HIV Infection
Interventions
DRUG

Atripla (r)

Patients are administered one tablet of Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF, Atripla) to taken be taken orally once daily at bedtime without food.

DRUG

Efavirenz

Participants will take one 600 mg tablet administered orally once daily without food.

DRUG

Truvada

Participants will take one tablet of Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF, Truvada) administered orally once daily with or without food.

DRUG

Rifampin/isoniazid/pyrazinamide/ethambutol FDC

Participants will be administered Rifampin/isoniazid/pyrazinamide/ethambutol FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 of the protocol, for the first 8 weeks.

DRUG

Rifampin/isoniazid FDC

Participants will be administered rifampin/isoniazid FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 in the protocol, for 16 weeks following the first 8 weeks.

DRUG

Isoniazid

INH 300 mg orally once daily

Trial Locations (18)

4011

CAPRISA eThekwini CRS, Durban

6110

Les Centres GHESKIO CRS, Port-au-Prince

20200

Walter Reed Project - Kenya Med. Research Institute Kericho CRS, Kericho

30100

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS, Eldoret

411001

BJ Medical College CRS, Pune

600113

YRG CARE Medical Ctr., VHS Chennai CRS, Rajiv Gandhi Salai Taramani

21045-900

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

Unknown

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince

College of Med. JHU CRS (30301), Blantyre

University of North Carolina Lilongwe CRS (12001), Lilongwe

San Miguel CRS, San Miguel

Wits HIV CRS, Johannesburg

Durban Adult HIV CRS, Durban

Soweto ACTG CRS (12301), Johannesburg

Joint Clinical Research Centre (JCRC) (12401), Kampala

Kalingalinga Clinic CRS (12801), Lusaka

UZ-Parirenyatwa CRS, AIDS Research Unit P.O. Box A178

18 PE

Barranco CRS (11301), Lima

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

NCT01380080 - REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment | Biotech Hunter | Biotech Hunter