Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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