Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: HIV Infections, Lipoatrophy

In brief

Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness of uridine supplementation in treating HIV infected individuals on stable ART with lipoatrophy.

Key facts

Study ID

NCT00307164

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

167

Starts

2006-09-01

Expected to finish

2008-12-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected
• Stable ART containing zidovudine or stavudine for at least 12 consecutive weeks prior to study entry
• Cumulative ART with zidovudine or stavudine for at least 24 weeks prior to study entry
• Viral load of 5,000 copies/ml or less within 45 days prior to study entry
• Lipoatrophy in at least two of the following areas: face, arms, legs, OR buttocks
• Not planning to add to or change current vitamin supplementation
• Willing to use acceptable forms of contraception

You may not qualify if…

• Life expectancy of less than 12 months
• Currently enrolled in or planning to enroll in an ART interruption study
• Plans to change current ART regimen
• Liver failure at anytime prior to study entry
• Greater than Grade 2 diarrhea or vomiting within 7 days prior to study entry
• Current AIDS-defining opportunistic infection or illness. Individuals with cutaneous Kaposi's sarcoma not requiring chemotherapy are not excluded.
• Currently receiving insulin or oral hypoglycemic products for diabetes mellitus
• Systemic cancer chemotherapy or immunomodulating agents within 30 days prior to study entry
• Systemic steroids for a cumulative duration of longer than 4 weeks within the 6 months prior to study entry
• Known allergy or sensitivity to study drug or any of its components
• Severe lactose intolerance
• Current drug or alcohol abuse or dependence
• Clinically significant illness requiring systemic treatment or hospitalization
• Chronic disability or serious illness that may affect body composition
• Received an investigational drug other than NucleomaxX or uridine for lipoatrophy within 30 days prior to study entry
• Certain abnormal laboratory values
• Pregnancy or breastfeeding

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Cornell CRS — New York, New York, United States
• HIV Prevention & Treatment CRS — New York, New York, United States
• Trillium Health ACTG CRS — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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