Phase 3
N=165
Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
HIV Infections · Lipoatrophy
Bottom Line
View on ClinicalTrials.gov: NCT00307164 ↗Enrolled (actual)
165
Serious AEs
3.6%
Results posted
Oct 2011
Primary outcome: Primary: Change in Limb Fat (g) From Baseline — 74; 110 grams — p=0.64
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NucleomaxX (Drug); NucleomaxX placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Limb Fat (g) From Baseline |
74; 110 | 0.64 |
| SECONDARY Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) |
47.1; 47.9 | 0.17 |
| SECONDARY Number of Subjects Discontinuing Study Medication |
34; 34 | — |
| SECONDARY Change in Limb Fat From Baseline (Week 24 - Baseline) |
54; 7 | 0.25 |
| SECONDARY HIV-1 RNA Level |
59; 54; 8; 15 | — |
| SECONDARY Change in CD4+ Count From Baseline (Week 48 - Baseline) |
33; 28 | 0.88 |
| SECONDARY Change in Fasting Lactate From Baseline (Week 48 - Baseline) |
0.2; 0.1 | 0.60 |
| SECONDARY Change in Fasting Glucose From Baseline (Week 48 - Baseline) |
2; 4 | 0.13 |
| SECONDARY Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) |
2; -6 | 0.17 |
| SECONDARY Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) |
1; -1 | 0.034 sig |
| SECONDARY Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline) |
2; 2 | 0.76 |
| SECONDARY Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline) |
1; -3 | 0.10 |
| SECONDARY Change in Fasting Triglycerides From Baseline (Week 48 - Baseline) |
-8; 13 | 0.43 |
| SECONDARY Change in Hemoglobin From Baseline (Week 48 - Baseline) |
0.3; 0 | 0.17 |
| SECONDARY Change in Leukocytes From Baseline (Week 48 - Baseline) |
0.2; 0.1 | 0.80 |
| SECONDARY Change in Creatine Kinase From Baseline (Week 48 - Baseline) |
1; 5 | 0.42 |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00307164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.