Status:
COMPLETED
Effects of Uridine Supplementation on Metabolic Side Effects of Stavudine and Zidovudine
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
HIV Infections
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 tre...
Detailed Description
Treatment of HIV infection with nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been associated with numerous toxicities that have been attributed to impaired mitochondrial function s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00471614
Start Date
April 1 2007
End Date
January 1 2012
Last Update
May 16 2012
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94110