Safety and Effectiveness of Low-Dose Methotrexate for Reducing Inflammation in HIV-Infected Adults on ARV Medications

PHASE2CompletedINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

December 8, 2016

Study Completion Date

December 8, 2016

Conditions
HIV Infections
Interventions
DRUG

LDMTX

"LDMTX 5 mg: one 5-mg capsule by mouth once weekly~LDMTX 10 mg: two 5-mg capsules by mouth once weekly~LDMTX 15 mg: three 5-mg capsules by mouth once weekly"

DRUG

Placebo

"Placebo 5 mg: one 5-mg capsule by mouth once weekly~Placebo 10 mg: two 5-mg capsules by mouth once weekly~Placebo 15 mg: three 5-mg capsules by mouth once weekly"

DIETARY_SUPPLEMENT

Folic acid

1-mg tablet of folic acid by mouth once a day

Trial Locations (22)

15213

University of Pittsburgh CRS, Pittsburgh

19104

Penn Therapeutics, CRS, Philadelphia

21205

Johns Hopkins University CRS, Baltimore

27401

Greensboro CRS, Greensboro

27599

Chapel Hill CRS, Chapel Hill

35294

Alabama CRS, Birmingham

37204

Vanderbilt Therapeutics (VT) CRS, Nashville

43210

Ohio State University CRS, Columbus

44106

Case Clinical Research Site, Cleveland

45219

Cincinnati Clinical Research Site, Cincinnati

60611

Northwestern University CRS, Chicago

77030

Houston AIDS Research Team CRS, Houston

80045

University of Colorado Hospital CRS, Aurora

90035

UCLA CARE Center CRS, Los Angeles

90502

Harbor-UCLA CRS, Torrance

92103

UCSD Antiviral Research Center CRS, San Diego

94110

Ucsf Hiv/Aids Crs, San Francisco

90033-1079

University of Southern California CRS, Los Angeles

02115

Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS, Boston

63110-1010

Washington University Therapeutics (WT) CRS, St Louis

07103

New Jersey Medical School Clinical Research Center CRS, Newark

02906

The Miriam Hospital Clinical Research Site (TMH CRS) CRS, Providence

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01949116 - Safety and Effectiveness of Low-Dose Methotrexate for Reducing Inflammation in HIV-Infected Adults on ARV Medications | Biotech Hunter | Biotech Hunter