Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00307164
First received: March 23, 2006
Last updated: November 25, 2013
Last verified: November 2013
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: HIV Infections
Lipoatrophy
Interventions: Drug: NucleomaxX
Drug: NucleomaxX placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between October 5, 2006 (date first subject was randomized) and January 7, 2008 (date last subject was randomized).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 167 subjects were randomized, and results are reported for 165 eligible participants; two subjects never started study medication and were excluded from all analyses. The subjects were stratified by antiretroviral therapy use, stavudine (d4T) or zidovudine (AZT/ZDV).

Reporting Groups
  Description
NucleomaxX Participants received NucleomaxX for uridine through week 48
Placebo Participants received NucleomaxX placebo through week 48

Participant Flow:   Overall Study
    NucleomaxX     Placebo  
STARTED     83     82  
COMPLETED     68     68  
NOT COMPLETED     15     14  
Death                 1                 0  
Severe debilitation, unable to continue                 1                 0  
Subject/parent not able to get to clinic                 2                 1  
Withdrawal by Subject                 1                 8  
Not compliant with requirements                 4                 4  
Lost to Follow-up                 6                 1  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Limb Fat (g) From Baseline   [ Time Frame: Baseline and Week 48 ]

2.  Secondary:   Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)   [ Time Frame: Through Week 48 ]

3.  Secondary:   Number of Subjects Discontinuing Study Medication   [ Time Frame: Through Week 48 ]

4.  Secondary:   Change in Limb Fat From Baseline (Week 24 - Baseline)   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   HIV-1 RNA Level   [ Time Frame: At Week 48 ]

6.  Secondary:   Change in CD4+ Count From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

7.  Secondary:   Change in Fasting Lactate From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

8.  Secondary:   Change in Fasting Glucose From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

9.  Secondary:   Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

10.  Secondary:   Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

11.  Secondary:   Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

12.  Secondary:   Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

13.  Secondary:   Change in Fasting Triglycerides From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

14.  Secondary:   Change in Hemoglobin From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

15.  Secondary:   Change in Leukocytes From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

16.  Secondary:   Change in Creatine Kinase From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: ClinicalTrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00307164     History of Changes
Other Study ID Numbers: A5229, 10136, ACTG A5229
Study First Received: March 23, 2006
Results First Received: August 23, 2011
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration