Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

This study has been completed.
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by:
Tibotec, Inc
ClinicalTrials.gov Identifier:
NCT00757783
First received: September 19, 2008
Last updated: February 3, 2014
Last verified: September 2012
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: ritonavir
Drug: darunavir
Drug: emtricitabine [FTC]/tenofovir [TDF]
Drug: atazanavir

  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
This is a phase 4, multicenter, open-label, randomized study (TMC114HIV4023). The study will be conducted at approximately 16 study sites in the United States. Approximately 60 HIV-1 infected, treatment-naive adult subjects will be enrolled in the study.

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
Darunavir darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Atazanavir atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Participant Flow:   Overall Study
    Darunavir     Atazanavir  
STARTED     34     31  
COMPLETED     32     30  
NOT COMPLETED     2     1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 1                 0  
Other                 0                 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
Darunavir darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Atazanavir atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Total Total of all reporting groups

Baseline Measures
    Darunavir     Atazanavir     Total  
Number of Participants  
[units: participants]
  34     31     65  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     34     30     64  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  35.9  ± 10.35     36.9  ± 11.66     36.4  ± 10.92  
Gender  
[units: participants]
     
Female     5     4     9  
Male     29     27     56  
Region of Enrollment  
[units: participants]
     
US     34     31     65  
log HIV-1 RNA  
[units: copies/mL]
Mean ± Standard Deviation
  5.016  ± 0.7846     4.562  ± 0.6535     4.800  ± 0.7549  



  Outcome Measures
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1.  Primary:   Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week 12.   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12.   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12.   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12.   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12.   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline in Apolipoprotein B in the LE Set at Week 12.   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change From Baseline in TC/HDL Ratio in the LE Set at Week 12.   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Change From Baseline in Glucose at Week 12.   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Change From Baseline in Insulin at Week 12.   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Change From Baseline in Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) at Week 12.   [ Time Frame: Baseline, Week 12 ]

11.  Secondary:   Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.   [ Time Frame: Baseline, Week 12 ]

12.  Secondary:   Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)   [ Time Frame: Baseline, Week 12 ]

13.  Secondary:   Change From Baseline in HIV-1 RNA Viral Load at Week 12.   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:   Change From Baseline in CD4 Cell Count at Week 12.   [ Time Frame: Baseline, Week 12 ]

15.  Secondary:   Change From Baseline in CD4 Cell Count at Week 12, Last Observation Carried Forward (LOCF).   [ Time Frame: Baseline, Week 12 ]


  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
65 subjects were enrolled/treated in the main study. 3 subjects were enrolled, randomized, not treated and excluded from analyses (n=68). An additional 18 subjects were enrolled in a substudy extension and excluded from the main analyses.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Tibotec Therapeutics Clinical Affairs
Organization: Tibotec Therapeutics Clinical Affairs (TTCA), Division of Centocor Ortho Biotech Services, LLC
phone: 877-732-2488


No publications provided by Tibotec, Inc

Publications automatically indexed to this study:

Responsible Party: Vice President, Clinical Affairs, Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
ClinicalTrials.gov Identifier: NCT00757783     History of Changes
Other Study ID Numbers: CR015439, TMC114HIV4023
Study First Received: September 19, 2008
Results First Received: August 12, 2010
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration