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Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00119405
First Posted: July 13, 2005
Last Update Posted: March 30, 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):
National Institute of Allergy and Infectious Diseases (NIAID)
Results First Submitted: June 13, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: HIV Infections
Lipodystrophy
Metabolic Diseases
Nutrition Disorders

  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
Recruitment occurred from 6/2005 to 11/2008. Participants were recruited from 3 HIV clinics in Cleveland, with the majority from the clinic at University Hospitals Case Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants had to be HIV+ and naive to ARVs.

Reporting Groups
  Description
ARV Naive ARV naive

Participant Flow:   Overall Study
    ARV Naive
STARTED   18 
COMPLETED   17 
NOT COMPLETED   1 
Withdrawal by Subject                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
ARV Naive ARV naive

Baseline Measures
   ARV Naive 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      18 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.88  (8.48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  33.3% 
Male      12  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   Mitochondrial Function (mtDNA Levels)   [ Time Frame: 96 weeks ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Grace McComsey
Organization: Case Western Reserve University
phone: 216-844-3607
e-mail: mccomsey.grace@clevelandactu.org



Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00119405     History of Changes
Other Study ID Numbers: 1R01AI060484-01A2A
1R01-AI060484-01A2A
1R01AI060484-01A2 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2005
First Posted: July 13, 2005
Results First Submitted: June 13, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017