High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART

PHASE2CompletedINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions
HIV-1 Infection
Interventions
DRUG

EFV/FTC/TDF

FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.

DRUG

Calcium Carbonate

Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.

DRUG

Vitamin D3

One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.

DRUG

Placebo for calcium carbonate

A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks

DRUG

Placebo for vitamin D3

A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Trial Locations (39)

10011

Cornell CRS (7804), New York

10016

NY Univ. HIV/AIDS CRS (401), New York

10032

HIV Prevention & Treatment CRS (30329), New York

10457

Bronx-Lebanon Hosp. Ctr. CRS (31469), The Bronx

14642

AIDS Care CRS (1108), Rochester

University of Rochester ACTG CRS (1101), Rochester

15213

Pittsburgh CRS (1001), Pittsburgh

19104

Hosp. of the Univ. of Pennsylvania CRS (6201), Philadelphia

20007

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

21201

IHV Baltimore Treatment CRS (4651), Baltimore

27401

Regional Center for Infectious Disease, Wendover Medical Center CRS (3203), Greensboro

27514

Unc Aids Crs (3201), Chapel Hill

27710

Duke University Medical Center Adult CRS (1601), Durham

30308

The Ponce de Leon Ctr. CRS (5802), Atlanta

35294

Alabama Therapeutics CRS (5801), Birmingham

37232

Vanderbilt Therapeutics CRS (3652), Nashville

43210

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

44106

Case CRS (2501), Cleveland

44109

MetroHealth CRS (2503), Cleveland

45267

Univ. of Cincinnati CRS (2401), Cincinnati

60611

Northwestern University CRS (2701), Chicago

60612

Rush University Medical Center (2702), Chicago

63110

Washington University CRS (2101), St Louis

75208

Trinity Health and Wellness Center CRS (31443), Dallas

77030

Houston AIDS Research Team CRS (31473), Houston

80045

University of Colorado Hospital CRS (6101), Aurora

90033

Usc Crs (1201), Los Angeles

90095

UCLA CARE Center CRS (601), Los Angeles

90502

Harbor-UCLA Med. Ctr. CRS (603), Torrance

92103

Ucsd, Avrc Crs (701), San Diego

94110

Ucsf Aids Crs (801), San Francisco

94304

Stanford CRS (501), Palo Alto

98104

University of Washington AIDS CRS (1401), Seattle

02114

Massachusetts General Hospital ACTG CRS (101), Boston

02115

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

02215

Beth Israel Deaconess Med. Ctr., ACTG CRS (103), Boston

07103

New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477), Newark

02906

The Miriam Hosp. 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

NCT01403051 - High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART | Biotech Hunter | Biotech Hunter