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Mechanisms of Lipodystrophy in HIV-Infected Pateints

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ClinicalTrials.gov Identifier: NCT00457665
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
GlaxoSmithKline
Information provided by:
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Nelfinavir
Drug: Efavirenz
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nelfinavir Efavirenz
Hide Arm/Group Description Randomized to receive Nelfinavir inclusive HAART Randomized to receive Efavirenz inclusive HAART
Period Title: 12 Months
Started 28 28
Completed 20 19
Not Completed 8 9
Reason Not Completed
Drug allergy             1             1
High HIV viral load             5             1
Lipodystrophy             2             0
Withdrawal by Subject             0             2
Abnormal Liver function tests             0             5
Period Title: 24 Months
Started 20 19
Completed 15 11
Not Completed 5 8
Reason Not Completed
Withdrawal by Subject             3             2
Lipodystrophy             1             1
Abnormal liver function tests             1             5
Arm/Group Title Nelfinavir Efavirenz Total
Hide Arm/Group Description Randomized to receive Nelfinavir inclusive HAART Randomized to receive Efavirenz inclusive HAART Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
5
  17.9%
4
  14.3%
9
  16.1%
Male
23
  82.1%
24
  85.7%
47
  83.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 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
5
  17.9%
5
  17.9%
10
  17.9%
White
14
  50.0%
19
  67.9%
33
  58.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
  32.1%
4
  14.3%
13
  23.2%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kgs
Number Analyzed 28 participants 28 participants 56 participants
75.4  (11) 75  (13.8) 75.18  (12.3)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 28 participants 28 participants 56 participants
25.2  (3.8) 24.8  (5) 24.9  (4.3)
CD4 count   [1] 
Mean (Standard Deviation)
Unit of measure:  Per cubic mm
Number Analyzed 28 participants 26 participants 54 participants
312  (210) 301  (158) 307  (185)
[1]
Measure Analysis Population Description: Data for 2 patients were not available
HIV Viral load   [1] 
Median (Full Range)
Unit of measure:  Copies per mL
Number Analyzed 28 participants 25 participants 53 participants
82000
(6230 to 750001)
103000
(5220 to 750001)
97900
(5220 to 750001)
[1]
Measure Analysis Population Description: Values for 3 participants were not available
Fasting plasma glucose   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 26 participants 27 participants 53 participants
92.5  (9.0) 90.3  (5.6) 91.4  (7.4)
[1]
Measure Analysis Population Description: Values of 3 participants were not available
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 28 participants 28 participants 56 participants
129  (83.8) 133.5  (81.4) 131.24  (82)
1.Primary Outcome
Title Effect of Drug Regimens on Serum Triglycerides.
Hide Description [Not Specified]
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects dropped before 1 year and some dropped between 1-2 years.
Arm/Group Title Nelfinavir (Viracept) Efavirenz (Sustiva)
Hide Arm/Group Description:
Assigned to Nelfinavir
Assigned to Efavirenz
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: mg/dL
At 12 months Number Analyzed 20 participants 20 participants
228.0  (119.0) 230.4  (157.3)
At 24 months Number Analyzed 14 participants 11 participants
293.4  (350.6) 290.0  (276.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nelfinavir (Viracept), Efavirenz (Sustiva)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nelfinavir Efavirenz
Hide Arm/Group Description These participants were randomized to receive Nelfinavir These participants were randomized to receive Efavirenz
All-Cause Mortality
Nelfinavir Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/28 (0.00%)    
Hide Serious Adverse Events
Nelfinavir Efavirenz
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/28 (3.57%)      2/28 (7.14%)    
Gastrointestinal disorders     
Gastritis  [1]  1/28 (3.57%)  1 0/28 (0.00%)  0
Vomiting and diarrhea  [1]  0/28 (0.00%)  0 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders     
Spider bite  [1]  0/28 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
[1]
Hospitalized
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nelfinavir Efavirenz
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/28 (71.43%)      20/28 (71.43%)    
Gastrointestinal disorders     
Diarrhea   13/28 (46.43%)  1/28 (3.57%) 
Hepatobiliary disorders     
Abnormal liver function tests  [1]  1/28 (3.57%)  1 10/28 (35.71%)  10
Nervous system disorders     
Peripheral neuropathy   6/28 (21.43%)  6 10/28 (35.71%)  10
Psychiatric disorders     
Disturbing dreams   2/28 (7.14%)  9/28 (32.14%) 
Skin and subcutaneous tissue disorders     
Skin rash   1/28 (3.57%)  1 5/28 (17.86%)  5
Indicates events were collected by systematic assessment
[1]
High values of aspartate aminotransferase or alanine aminotransferase
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Abhimanyu Garg
Organization: UTSouthwestern Medical Center
Phone: 214-648-2895
EMail: abhimanyu.garg@utsouthwestern.edu
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00457665    
Other Study ID Numbers: R01-56583
First Submitted: April 4, 2007
First Posted: April 6, 2007
Results First Submitted: May 8, 2019
Results First Posted: July 18, 2019
Last Update Posted: July 18, 2019