Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

October 25, 2013

Primary Completion Date

May 21, 2015

Study Completion Date

July 31, 2017

Conditions
HIVHIV InfectionsAcquired Immunodeficiency Syndrome
Interventions
DRUG

TAF

25 mg tablet administered orally once daily with food

DRUG

Placebo

Tablets to match TAF administered orally once daily with food

DRUG

E/C/F/TAF

150/150/200/10 mg STR administered orally once daily with food

DRUG

Current failing ARV regimen

Participants will continue taking their current ARV regimen as prescribed in Part 1.

DRUG

ATV

300 mg tablet administered orally once daily.

Trial Locations (15)

10330

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok

10400

Ramathibodi Hospital, Mahidol University, Bangkok

10514

Salvador B Gautier Hospital - Infectious Diseases Department, Santo Domingo

10700

Siriraj Hospital Department of Preventive and Social Medicine, Faculty of Medicine, Bangkok

19104

Penn Presbyterian Medical Center, Philadelphia

27157

Wake Forest University Health Sciences, Winston-Salem

33305

Rowan Tree Medical, P.A., Wilton Manors

33401

Triple O Research Institute, P.A., West Palm Beach

34982

Midway Immunology and Research center, Ft. Pierce

40002

Khon Kaen University, Khon Kaen

50200

Chiang Mai University, Chiang Mai

190020

Center For Prevention and Treatment of AIDS and Infectious Diseases, Saint Petersburg, Saint Petersburg

660049

Regional state budget health agency Krasnoyarsk Regional Center for Prevention and Control of AIDS, Krasnoyarsk

Unknown

Instituto Dominicano de Estudio Virologicos - IDEV, Santo Domingo

Joint Clinical Research Centre, Kampala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY