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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 February 2014
Main ID:  NCT00307164
Date of registration: 23/03/2006
Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Public title: Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
Scientific title: A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Trial of Uridine Supplementation in HIV Lipoatrophy
Date of first enrolment: September 2006
Target sample size: 167
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00307164
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment  
Countries of recruitment
Puerto Rico United States
Contacts
Name:   Grace A. McComsey, MD
Address: 
Telephone:
Email:
Affiliation:  Division of Infectious Diseases, Case Western Reserve University
Name:   Judith A. Aberg, MD
Address: 
Telephone:
Email:
Affiliation:  New York University
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
HIV Infections
Lipoatrophy
Intervention(s)
Drug: NucleomaxX
Drug: NucleomaxX placebo
Primary Outcome(s)
Change in Limb Fat (g) From Baseline [Time Frame: Baseline and Week 48]
Secondary Outcome(s)
Change in CD4+ Count From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Creatine Kinase From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Fasting Glucose From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Fasting Lactate From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Fasting Triglycerides From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Hemoglobin From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Leukocytes From Baseline (Week 48 - Baseline) [Time Frame: Baseline and Week 48]
Change in Limb Fat From Baseline (Week 24 - Baseline) [Time Frame: Baseline and Week 24]
HIV-1 RNA Level [Time Frame: At Week 48]
Number of Subjects Discontinuing Study Medication [Time Frame: Through Week 48]
Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) [Time Frame: Through Week 48]
Secondary ID(s)
10136
A5229
ACTG A5229
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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