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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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NucleomaxX Participants received NucleomaxX for uridine through week 48
Placebo Participants received NucleomaxX placebo through week 48
Total Total of all reporting groups

Baseline Measures
   NucleomaxX   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   82   165 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.4  (7.78)   48.4  (6.46)   48.4  (7.13) 
Age, Customized 
[Units: Participants]
     
30-39 Years   9   10   19 
40-49 Years   38   32   70 
50-59 Years   28   38   66 
60-69 Years   8   2   10 
Gender 
[Units: Participants]
     
Female   8   7   15 
Male   75   75   150 
Race/Ethnicity, Customized 
[Units: Participants]
     
White Non-Hispanic   50   52   102 
Black Non-Hispanic   11   14   25 
Hispanic (Regardless of Race)   15   12   27 
Asian, Pacific Islander   3   1   4 
Native American, Alaskan Native   3   2   5 
Other (More than One Race)   1   0   1 
Unknown   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   81   81   162 
Puerto Rico   2   1   3 
Antiretroviral Therapy Used (Stratification) 
[Units: Participants]
     
AZT-Containing   63   63   126 
d4T-Containing   20   19   39 
HIV-1 RNA (copies/mL) Category 
[Units: Participants]
     
<=50 Copies   70   64   134 
>50 Copies   13   18   31 
CD4+ Count (NucleomaxX sample size (N)=80, Placebo N=80) 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 506 
 (353 to 724) 
 504 
 (376 to 710) 
 506 
 (359 to 714) 
Limb fat 
[Units: Grams]
Median (Inter-Quartile Range)
 3149 
 (1833 to 4210) 
 2995 
 (2082 to 4847) 
 3037 
 (2002 to 4403) 
Trunk fat 
[Units: Grams]
Median (Inter-Quartile Range)
 8175 
 (5784 to 10931) 
 7795 
 (5327 to 10825) 
 8114 
 (5397 to 10898) 
Fasting lactate (NucleomaxX N=76, Placebo N=75) 
[Units: mmol/L]
Median (Inter-Quartile Range)
 1.3 
 (1.0 to 1.7) 
 1.2 
 (0.9 to 1.5) 
 1.3 
 (0.9 to 1.6) 
Fasting glucose (NucleomaxX N=82, Placebo N=82) 
[Units: mg/dL]
Median (Inter-Quartile Range)
 90 
 (84 to 98) 
 87 
 (81 to 95) 
 89 
 (82 to 97) 
Fasting total cholesterol (NucleomaxX N=82, Placebo N=81) 
[Units: mg/dL]
Median (Inter-Quartile Range)
 194 
 (163 to 216) 
 190 
 (166 to 211) 
 193 
 (166 to 215) 
Fasting high-density lipoprotein (HDL) (NucleomaxX N=82, Placebo N=80) 
[Units: mg/dL]
Median (Inter-Quartile Range)
 39 
 (33 to 49) 
 37 
 (31 to 47) 
 38 
 (32 to 49) 
Fasting non-high-density lipoprotein (non-HDL) (NucleomaxX N=77, Placebo N=69) 
[Units: mg/dL]
Median (Inter-Quartile Range)
 139 
 (123 to 168) 
 145 
 (115 to 166) 
 143 
 (121 to 167) 
Fasting low-density lipoprotein (LDL) (NucleomaxX N=73, Placebo N=67) 
[Units: mg/dL]
Median (Inter-Quartile Range)
 107 
 (88 to 132) 
 110 
 (89 to 127) 
 109 
 (88 to 130) 
Fasting triglycerides (NucleomaxX N=82, Placebo N=81) 
[Units: mg/dL]
Median (Inter-Quartile Range)
 161 
 (112 to 237) 
 165 
 (114 to 262) 
 164 
 (114 to 258) 
Hemoglobin 
[Units: g/dL]
Median (Inter-Quartile Range)
 14.9 
 (13.7 to 15.6) 
 15.0 
 (14.0 to 15.8) 
 14.9 
 (13.8 to 15.7) 
Leukocytes 
[Units: cells*10^3/L]
Median (Inter-Quartile Range)
 5.6 
 (4.2 to 7.1) 
 5.5 
 (4.7 to 7.0) 
 5.5 
 (4.5 to 7.0) 
Creatine kinase (NucleomaxX N=80, Placebo N=82) 
[Units: IU/L]
Median (Inter-Quartile Range)
 125 
 (79 to 216) 
 142 
 (88 to 247) 
 134 
 (84 to 231) 


  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 ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)
Measure Description No text entered.
Time Frame Baseline and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat analysis with LOCF if week 48 fasting HDL data was missing and post-baseline fasting HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).

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

Measured Values
   NucleomaxX   Placebo 
Participants Analyzed 
[Units: Participants]
 77   73 
Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) 
[Units: mg/dL]
Median (Inter-Quartile Range)
 1 
 (-3 to 4) 
 -1 
 (-6 to 2) 


Statistical Analysis 1 for Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)
Groups [1] All groups
Method [2] Stratified Wilcoxon rank-sum test
P Value [3] 0.034
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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


  Limitations and Caveats
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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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  More Information