Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis & T-cells

PHASE2CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

April 14, 2011

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
HIV-1 Infection
Interventions
DRUG

atorvastatin

10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4- week 20

DRUG

atorvastatin

Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.

DRUG

placebo for atorvastin

One tablet once daily for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, then increase the dose to two tablets once daily.

Trial Locations (31)

10011

Cornell CRS (7804), New York

10016

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

14642

AIDS Care CRS (1101), Rochester

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

15213

Pitt CRS (1001), Pittsburgh

19104

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

20007

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

23219

Virginia Commonwealth Univ. Medical Ctr. CRS (31475), Richmond

27516

Unc Aids Crs (3201), Chapel Hill

27710

Duke Univ. Med. Ctr. Adult CRS (1601), Durham

35294

31788 Alabama CRS, Birmingham

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

48201

Wayne State Univ. CRS (31478), Detroit

48202

Henry Ford Hosp. CRS (31472), Detroit

60611

Northwestern University CRS (2701), Chicago

63110

Washington U CRS (2101), St Louis

77030

Houston AIDS Research Team CRS (31473), Houston

80045

University of Colorado Hospital CRS (6101), Aurora

90095

UCLA CARE Center CRS (601), Los Angeles

90502

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

92103

Ucsd, Avrc Crs (701), San Diego

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

08103

Cooper Univ. Hosp. CRS (31476), Camden

07103

New Jersey Medical School-Adult Clinical Research Ctr. CRS (31486), Newark

00935

Puerto Rico-AIDS CRS (5401), San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Pfizer

INDUSTRY

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK