Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
- Conditions
- HIV InfectionsLipoatrophy
- Interventions
- Drug: NucleomaxXDrug: NucleomaxX placebo
- Registration Number
- NCT00307164
- Brief 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.
- Detailed Description
Lipoatrophy is a distressing long-term complication of ART and is associated with decreased quality of life, an increased risk of cardiovascular disease, and nonadherence to ART. The cause of lipoatrophy in HIV-infected individuals receiving ART is not completely understood. However, past research suggests that mitochondrial toxicity in subcutaneous adipose tissue caused by thymidine analogue nucleoside analogues may be responsible for the development of lipoatrophy.
Uridine is a nucleoside that has been shown to be an effective supplement in treating individuals with mitochondrial toxicity. NucleomaxX is a food supplement that consists of mitocnol, a sugar cane extract that has a high content of nucleosides, including uridine. The purpose of this study was to evaluate the effects of uridine supplementation in the form of NucleomaxX on limb fat in HIV-infected individuals receiving stable ART containing stavudine (d4T) or zidovudine (ZDV). In addition, this study evaluated the safety and tolerability of NucleomaxX.
This study lasted for 48 weeks. Participants were randomly assigned to one of two treatment arms, stratified by d4T or ZDV use. Arm A participants received NucleomaxX for uridine, while Arm B participants received a placebo for NucleomaxX. Participants in both arms received their assigned intervention three times per day, every other day, for the duration of the study. There were 8 study visits over the 48-week study duration. Blood collection and a physical exam occurred at all study visits, and participants completed an adherence assessment at most visits. Participants underwent dual energy X-ray absorptiometry scans (DEXA) within 14 days prior to or following the screening visit and at other selected visits. Specific fasting tests for glucose and lipid levels occurred at selected visits. ART was not provided by this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NucleomaxX NucleomaxX Participants received NucleomaxX for 48 weeks Placebo NucleomaxX placebo Participants received NucleomaxX placebo for 48 weeks
- Primary Outcome Measures
Name Time Method Change in Limb Fat (g) From Baseline Baseline and Week 48 Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
- Secondary Outcome Measures
Name Time Method Change in Fasting Glucose From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Creatine Kinase From Baseline (Week 48 - Baseline) Baseline and Week 48 Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) Through Week 48 Time to safety events (grade 3 \[Severe\] or 4 \[life-threatening\] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry
Number of Subjects Discontinuing Study Medication Through Week 48 Number of eligible subjects who discontinued study medication during the study period.
Change in Limb Fat From Baseline (Week 24 - Baseline) Baseline and Week 24 Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups.
HIV-1 RNA Level At Week 48 Change in CD4+ Count From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Fasting Lactate From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Fasting Triglycerides From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Hemoglobin From Baseline (Week 48 - Baseline) Baseline and Week 48 Change in Leukocytes From Baseline (Week 48 - Baseline) Baseline and Week 48
Trial Locations
- Locations (30)
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
HIV Prevention & Treatment CRS
🇺🇸New York, New York, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Cornell CRS
🇺🇸New York, New York, United States
The Miriam Hosp. ACTG CRS
🇺🇸Providence, Rhode Island, United States
The Ponce de Leon Ctr. CRS
🇺🇸Atlanta, Georgia, United States
Beth Israel Med. Ctr., ACTU
🇺🇸New York, New York, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Vanderbilt Therapeutics CRS
🇺🇸Nashville, Tennessee, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
USC CRS
🇺🇸Los Angeles, California, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Trillium Health ACTG CRS
🇺🇸Rochester, New York, United States
Duke Univ. Med. Ctr. Adult CRS
🇺🇸Durham, North Carolina, United States