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Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433992
First Posted: February 12, 2007
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Grace McComsey, National Institute of Allergy and Infectious Diseases (NIAID)
Results First Submitted: March 28, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections

  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
ABC/3TC HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
TDF/FTC HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)

Participant Flow:   Overall Study
    ABC/3TC   TDF/FTC
STARTED   28   28 
COMPLETED   19   20 
NOT COMPLETED   9   8 



  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
ABC/3TC HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
TDF/FTC HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
Total Total of all reporting groups

Baseline Measures
   ABC/3TC   TDF/FTC   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   28   56 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      28 100.0%      28 100.0%      56 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  10.7%      4  14.3%      7  12.5% 
Male      25  89.3%      24  85.7%      49  87.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8  28.6%      4  14.3%      12  21.4% 
White      10  35.7%      12  42.9%      22  39.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      10  35.7%      12  42.9%      22  39.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mitochondrial Activity   [ Time Frame: Entry, Week 96 ]

2.  Secondary:   Change in Fat Apoptosis   [ Time Frame: Entry, 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
Limitations included small sample size and premature study discontinuation before week 96


  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: Case Western Reserve University
phone: 216-844-2739
e-mail: mccomsey.grace@clevelandactu.org



Responsible Party: Grace McComsey, National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00433992     History of Changes
Other Study ID Numbers: 1R01AI065348-01A2 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2007
First Posted: February 12, 2007
Results First Submitted: March 28, 2017
Results First Posted: July 31, 2017
Last Update Posted: September 4, 2017