A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment

PHASE3CompletedINTERVENTIONAL
Enrollment

426

Participants

Timeline

Start Date

October 2, 2013

Primary Completion Date

October 22, 2015

Study Completion Date

July 2, 2020

Conditions
Human Immunodeficiency Virus-type 1 Infection
Interventions
DRUG

Rilpivirine

Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

DRUG

Efavirenz

Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

DRUG

Tenofovir disoproxil fumarate

Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.

DRUG

Emtricitabine

Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.

Trial Locations (18)

Unknown

Douala

Yaoundé

Eldoret

Kangemi, Nairobi

Nairobi

Nyanza

Dakar

Pikine

Bloemfontein

Johannesburg

Soweto

Wentworth, Durban

Westville, KwaZulu

Amphur Mueang Nonthaburi

Bangkok

Chiang Mai

Entebbe

Kampala

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY

NCT01709084 - A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment | Biotech Hunter | Biotech Hunter