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

Completed · Phase 2

Conditions studied: HIV Infections, Insulin Resistance, Hyperlactatemia

In brief

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.

Key facts

Study ID

NCT00471614

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

3

Starts

2007-04-01

Expected to finish

2012-01-01

Last updated by the study team

2012-05-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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