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

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ClinicalTrials.gov Identifier: NCT00119405
Recruitment Status : Completed
First Posted : July 13, 2005
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: HIV Infections
Metabolic Diseases
Nutrition Disorders

  Participant Flow

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
ARV Naive ARV naive

Participant Flow:   Overall Study
    ARV Naive
Withdrawal by Subject                1 

  Baseline Characteristics

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.
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Reporting Groups
ARV Naive ARV naive

Baseline Measures
   ARV Naive 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      18 100.0% 
>=65 years      0   0.0% 
[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

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

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
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