Effects of Uridine Supplementation on Metabolic Side Effects of Stavudine and Zidovudine

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether uridine supplementation will improve insulin sensitivity and overall carbohydrate metabolism in HIV-positive subjects who are currently undergoing treatment with antiretroviral regimens containing stavudine or zidovudine and who have evidence of impaired mitochondrial function and insulin resistance.

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

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• Confirmed HIV-1 infection

• HIV-1 RNA <10,000 copies/mL within 30 days of study entry

• Treatment with stavudine or zidovudine for at least 12 months prior to entry and no plan to discontinue for the duration of the study

• Stable antiretroviral regimen for at least 3 months prior to entry and no plan to change antiretroviral therapy for the duration of the study

• Mitochondrial dysfunction as evidenced by a fasting plasma lactate level > 1.5 mmol/L

• Insulin resistance as evidenced by a HOMA-IR > 2.77 as calculated from fasting blood samples (for glucose and insulin) obtained during the screening visit

• Karnofsky performance score >= 80

• Women who are on stable regimens of hormonal contraceptives or hormone replacement therapy for at least 6 months prior to enrollment may participate

• Men who are on stable doses of testosterone replacement therapy for 6 months prior to enrollment may participate

• Subjects on a stable dose of lipid lowering agents for 6 months prior to enrollment may participate

Exclusion Criteria:

• Serum creatinine and blood urea nitrogen > 1.5 upper limit of normal (ULN)

• Direct bilirubin >2 X ULN

• AST (SGOT) or ALT (SGPT) >5 x ULN

• Hgb < 8.5 g/dL

• Abnormal hepatitis B or C serology

• A clinical diagnosis of diabetes mellitus or a fasting glucose > 126 mg/dl

• Physical or functional obstruction to food intake or impaired absorption

• A clinically suspected concomitant treatable infection that has not yet been treated

• An opportunistic infection within the preceding 30 days

• Ascites

• Pregnancy

• Treatment with growth hormone, anabolic steroids (including supraphysiologic doses of testosterone), glucocorticoids, insulin, sulfonylureas, metformin, thiazolidinediones, or appetite stimulants within preceding 6 months

• Dementia, active drug or alcohol abuse or dependence, or other conditions that would preclude adherence to the protocol or the ability to provide informed consent.

• Any other condition that, in the opinion of the investigators, would put the subject at risk