Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

PHASE2CompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

January 17, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
HIV-1 Infection
Interventions
DRUG

Darunavir

Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

DRUG

Ritonavir

Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

DRUG

Tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

DRUG

Emtricitabine

Emtricitabine was administered orally once a day as one 200 mg capsule.

DRUG

Placebo for Tenofovir disoproxil fumarate

Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

DRUG

Placebo for Maraviroc

Placebo for maraviroc was administered orally once a day as one tablet.

DRUG

Maraviroc

Maraviroc was administered orally once a day as one 150 mg tablet.

Trial Locations (38)

10032

Columbia Physicians and Surgeons CRS (30329), New York

14642

Trillium Health ACTG CRS (1108), Rochester

University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787), Rochester

19104

Hops. of Univ. of Pennsylvania CRS (6201), Philadelphia

20007

Georgetown University CRS (GU CRS) (1008), Washington D.C.

20010

Children's National Med. Ctr. ATN CRS (33003), Washington D.C.

21201

IHV Baltimore Treatment CRS (4651), Baltimore

21205

201 Johns Hopkins University CRS, Baltimore

27401

Moses H. Cone Memorial Hospital CRS (3203), Greensboro

27516

Unc Aids Crs (3201), Chapel Hill

30308

The Ponce de Leon Center CRS (5802), Atlanta

33136

Univ. of Miami AIDS CRS (901), Miami

33606

Univ. of South Florida (USF) College of Medicine ATN CRS (33001), Tampa

35294

31788 Alabama CRS, Birmingham

37232

Vanderbilt Therapeutics CRS (3652), Nashville

38105

St. Jude Children's Research Hosp. ATN CRS (33016), Memphis

43210

The Ohio State Univ. AIDS CRS (2301), Columbus

44106

Case CRS (2501), Cleveland

44109

Metro Health CRS (2503), Cleveland

45267

Univ. of Cincinnati CRS (2401), Cincinnati

60611

Northwestern University CRS (2701), Chicago

60612

Rush Univ. Med. Ctr. ACTG CRS (2702), Chicago

63110

Washington U CRS (2101), St Louis

75215

Peabody Health Center CRS (31443), Dallas

77030

Houston AIDS Research Team CRS (31473), Houston

Texas Childrens Hospital ATN CRS (33018), Houston

80045

University of Colorado Hospital CRS (6101), Aurora

80262

University of Colorado Denver ATN CRS (33022), Denver

90095

UCLA CARE Center CRS (601), Los Angeles

92103

Ucsd, Avrc Crs (701), San Diego

94110

Ucsf Aids Crs (801), San Francisco

98104

University of Washington AIDS CRS (1401), Seattle

90033-1079

University of Southern California (1201), Los Angeles

02114

Massachusetts General Hospital ACTG CRS (101), Boston

02115

Brigham and Women's Hosp. ACTG CRS (107), Boston

08103

Cooper Univ. Hosp. CRS (31476), Camden

02906

The Miriam Hospital ACTG CRS (2951), Providence

00935

Puerto Rico-AIDS CRS (5401), San Juan

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

NCT01400412 - Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen | Biotech Hunter | Biotech Hunter