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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: May 17, 2012
Last verified: May 2012
History of Changes
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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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  
Number of Participants  
[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
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1.  Primary:   Change in Limb Fat (g) From Baseline   [ Time Frame: Baseline and Week 48 ]
  Show Outcome Measure 1

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

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

Measure Type Secondary
Measure Title Number of Subjects Discontinuing Study Medication
Measure Description Number of eligible subjects who discontinued study medication during the study period.
Time Frame Through 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 based on all subjects who started study treatment.

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

Measured Values
    NucleomaxX     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  83     82  
Number of Subjects Discontinuing Study Medication  
[units: Participants]
 		  34     34  

No statistical analysis provided for Number of Subjects Discontinuing Study Medication



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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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  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
No text entered.  


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: May 17, 2012
Health Authority: United States: Food and Drug Administration