Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy (NCT00307164) | Clinical Trial Compass
CompletedPhase 2/3
Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
United States167 participantsStarted 2006-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 seri…
What they're measuring
1
Change in Limb Fat (g) From Baseline
Timeframe: Baseline and Week 48
Trial details
NCT IDNCT00307164
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)