460
Participants
Start Date
September 11, 2015
Primary Completion Date
November 28, 2018
Study Completion Date
November 28, 2018
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"
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."
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
Merck Sharp & Dohme LLC
INDUSTRY
Ministry of Health, Brazil
OTHER_GOV
ANRS, Emerging Infectious Diseases
OTHER_GOV