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Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grace McComsey, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00119379
First received: July 11, 2005
Last updated: May 15, 2017
Last verified: May 2017
Results First Received: December 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: HIV Infections
Lipodystrophy
Metabolic Diseases
Nutrition Disorders
Interventions: Drug: NucleomaxX
Drug: Tenofovir Disoproxil Fumarate

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Uridine Supplementation

NucleomaxX 36 grams TID every other day

NucleomaxX: NucleomaxX 36 grams TID every other day

Switch to TDF

Switch of AZT or d4T to tenofovir

Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir


Participant Flow:   Overall Study
    Uridine Supplementation   Switch to TDF
STARTED   26   24 
COMPLETED   22   23 
NOT COMPLETED   4   1 
Adverse Event                4                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
Uridine Supplementation

NucleomaxX 36 grams TID every other day

NucleomaxX: NucleomaxX 36 grams TID every other day

Switch to TDF

Switch of AZT or d4T to tenofovir

Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir

Total Total of all reporting groups

Baseline Measures
   Uridine Supplementation   Switch to TDF   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   24   50 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      26 100.0%      24 100.0%      50 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 48 
 (41 to 51) 
 48 
 (43 to 51) 
 48 
 (41 to 51) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  15.4%      3  12.5%      7  14.0% 
Male      22  84.6%      21  87.5%      43  86.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   26   24   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Fat mtDNA Content   [ Time Frame: Baseline to Week 48 ]

2.  Primary:   Change in PBMC mtDNA   [ Time Frame: Baseline to Week 48 ]

3.  Secondary:   Change in Limb Fat   [ Time Frame: Baseline to Week 48 ]

4.  Secondary:   Change in Trunk Fat   [ Time Frame: Baseline to Week 48 ]

5.  Secondary:   Change in Lumbar Spine Bone Mineral Density (BMD)   [ Time Frame: Baseline to Week 48 ]

6.  Secondary:   Change in Hip Bone Mineral Density (BMD)   [ Time Frame: Baseline to 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
Small sample size; Lack of control arm where tNRTI therapy was continued without any intervention; Adherence measured by sachet/pill count method.


  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.


Results Point of Contact:  
Name/Title: Dr. Grace McComsey
Organization: University Hospitals Case Medical Center
phone: 216-844-2739
e-mail: mccomsey.grace@clevelandactu.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Grace McComsey, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00119379     History of Changes
Other Study ID Numbers: 1R01AI060484-01A2B
R01AI060484 ( U.S. NIH Grant/Contract )
Study First Received: July 11, 2005
Results First Received: December 8, 2016
Last Updated: May 15, 2017