ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00119405
Recruitment Status : Completed
First Posted : July 13, 2005
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
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
Lipodystrophy
Metabolic Diseases
Nutrition Disorders
Enrollment 18
Recruitment Details 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 Participants had to be HIV+ and naive to ARVs.
Arm/Group Title ARV Naive
Hide Arm/Group Description ARV naive
Period Title: Overall Study
Started 18
Completed 17
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title ARV Naive
Hide Arm/Group Description ARV naive
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
33.88  (8.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
6
  33.3%
Male
12
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Mitochondrial Function (mtDNA Levels)
Hide Description Mitochondrial gene expression: mtDNA levels are used to quantify this outcome measure.
Time Frame 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ARV Naive
Hide Arm/Group Description:
ARV naive (have never been on antiretrovirals before)
Overall Number of Participants Analyzed 18
Mean (95% Confidence Interval)
Unit of Measure: copies per cell
1372
(532 to 2721)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ARV Naive
Hide Arm/Group Description ARV naive (have never been on antiretrovirals before)
All-Cause Mortality
ARV Naive
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ARV Naive
Affected / at Risk (%) # Events
Total   2/18 (11.11%)    
Endocrine disorders   
Pancreatitis (Grade 3)  1/18 (5.56%)  1
Metabolism and nutrition disorders   
Hypokalemia (Grade 2)  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Right Lower Lobe (RLL) Pneumonia (Grade 3)  1/18 (5.56%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ARV Naive
Affected / at Risk (%) # Events
Total   12/18 (66.67%)    
Blood and lymphatic system disorders   
Low absolute neutrophil count (ANC) (Grades 2 and 3)  2/18 (11.11%)  3
Low white blood cell (WBC) count (Grade 2)  1/18 (5.56%)  2
Cardiac disorders   
Tachycardia (Grade 2)  1/18 (5.56%)  1
Hepatobiliary disorders   
Elevated Aspartate aminotransferase (AST) (Grades 2 and 3)  3/18 (16.67%)  3
Elevated alanine aminotransferase (ALT) 207 (Grade 2)  1/18 (5.56%)  1
Metabolism and nutrition disorders   
Low glucose 34 (Grade 3) [1]  1/18 (5.56%)  1
Low glucose 48 (Grade 2)  1/18 (5.56%)  1
Elevated Cholesterol 257 (Grade 2)  1/18 (5.56%)  1
Elevated low-density lipoprotein (LDL) 175 (Grade 2)  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Bone Mineral Density (BMD)/T scores -2.3 and -3.2 [2]  1/18 (5.56%)  1
Elevated creatine kinase (CK) levels (Grades 3 and 4)  3/18 (16.67%)  3
Skin and subcutaneous tissue disorders   
Incisional Seroma  1/18 (5.56%)  1
Incisional Hematoma (Grade 1)  2/18 (11.11%)  2
Infected Incisional Hematoma (Grade 2)  1/18 (5.56%)  1
Rash  1/18 (5.56%)  1
[1]
Lab delay - repeated result was 105
[2]
Known osteoporosis pre-study
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
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