Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

PHASE3CompletedINTERVENTIONAL
Enrollment

460

Participants

Timeline

Start Date

September 11, 2015

Primary Completion Date

November 28, 2018

Study Completion Date

November 28, 2018

Conditions
HIV-1 InfectionTuberculosis
Interventions
DRUG

Tenofovir + lamivudine + raltegravir

"In this arm, patients will receive the following medications :~* Tenofovir disoproxil fumarate (TDF) 300 mg / Lamivudine (3TC) 300 mg FDC once a day (1 tablet qd)~* Raltegravir (RAL) 400 mg (Isentress®): twice daily (1 tablet bid), with food~In countries where TDF/3TC FDC is not available, the following separate drugs will be used:~* Tenofovir disoproxil fumarate (TDF) 300 mg (Viread® 245 mg): once a day (1 tablet qd)~* Lamivudine (3TC) : 300 mg once a day (300 mg, 1 tablet qd or 150 mg 2 tablets qd)~* Raltegravir (RAL) 400 mg (Insentress®): twice daily (1 tablet bid), with food"

DRUG

Tenofovir + lamivudine + efavirenz

"In this arm, patients will receive the following medications, in accordance with treatment guidelines in all countries:~* Tenofovir disoproxil fumarate (TDF) 300 mg / lamivudine (3TC) 300 mg FDC once a day (1 tablet qd)~* Efavirenz (EFV) 600 mg: once a day, at night (1 tablet qd)~OR:~• Tenofovir disoproxil fumarate (TDF) 245 300 mg / lamivudine (3TC) 300 mg / efavirenz (EFV) 600 mg: once a day (1 tablet qd), at night, if possible without food~In countries where TDF/3TC FDC is not available, the following separate drugs will be used:~* Tenofovir disoproxil fumarate (TDF) 300 mg (Viread® 245 mg): once a day (1 tablet qd)~* Lamivudine (3TC): 300 mg once a day (300 mg, 1 tablet qd or 150 mg 2 tablets qd)~* Efavirenz (EFV) 600 mg: once a day, at night (1 tablet qd), if possible without food. The dose will not be adapted to the patient's body weight."

Trial Locations (5)

Unknown

Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ, Rio de Janeiro

PACCI / CePReF Centre de Prise en charge de Recherche et de Formation, Abidjan

Hôpital Saint Louis, Paris

Instituto Nacional de Saude / Hospital Geral de Machava, Maputo

Pham Ngoc Thach Hospital, Ho Chi Minh City

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Ministry of Health, Brazil

OTHER_GOV

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT02273765 - Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis | Biotech Hunter | Biotech Hunter