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Switching From Efavirenz to Atazanavir/ Ritonavir in HIV-infected Subjects With Good Virologic Suppression

This study has been terminated.
(Closed due to low enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194856
First Posted: September 3, 2010
Last Update Posted: August 11, 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.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Case Western Reserve University
Bristol-Myers Squibb
Information provided by (Responsible Party):
Marisa Tungsiripat, The Cleveland Clinic
Results First Submitted: January 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV Infection
Mitochondrial Dysfunction
Interventions: Drug: Atazanavir/ritonavir
Drug: Efavirenz

  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
No text entered.

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
Efavirenz 600 mg

Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen

Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks

Arm B - Atazanavir/Ritonavir

Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks

Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks


Participant Flow:   Overall Study
    Efavirenz 600 mg   Arm B - Atazanavir/Ritonavir
STARTED   1   0 
COMPLETED   0   0 
NOT COMPLETED   1   0 



  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
Efavirenz 600 mg

Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen

Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks

Arm B - Atazanavir/Ritonavir

Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks

Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks

Total Total of all reporting groups

Baseline Measures
   Efavirenz 600 mg   Arm B - Atazanavir/Ritonavir   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%         0   0.0% 
Between 18 and 65 years      1 100.0%         1 100.0% 
>=65 years      0   0.0%         0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%         0   0.0% 
Male      1 100.0%         1 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1      1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in DEXA-measured Limb Fat Between the EFV and ATV/r Arms   [ Time Frame: 48 weeks ]

2.  Secondary:   Compare Changes for DEXA-measured Limb Fat Between EFV and ATV/r Arms   [ Time Frame: 96 weeks ]

3.  Secondary:   Compare Changes in CD4, HIV-1 RNA Levels and Adverse Events in Two Arms   [ Time Frame: 96 weeks ]

4.  Secondary:   Compare Changes in Fat mtDNA, mtRNA and Fat Apoptosis Between the Two Arms   [ Time Frame: 96 weeks ]

5.  Secondary:   Comparing Fasting Lipid Levels Between the Two Arms   [ Time Frame: 96 weeks ]

6.  Secondary:   Comparing Glucose Metabolism (Fasting Insulin, QUIKI and HOMA-IR) Between the Two Arms   [ Time Frame: 96 weeks ]

7.  Secondary:   Compare Changes in Levels of Hs-CRP Between the Two Arms   [ Time Frame: 96 weeks ]

8.  Secondary:   Correlate the Changes in DEXA-measured Fat Limb With Fat mtDNA, mtRNA and Fat Apoptosis   [ 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
Data not collected for analysis due to low enrollment and participant discontinuation.


  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: Marisa Tungsiripat
Organization: Cleveland Clinic
phone: 2164442037
e-mail: tungsim@ccf.org



Responsible Party: Marisa Tungsiripat, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01194856     History of Changes
Other Study ID Numbers: 10-418
5K23AI070078 ( U.S. NIH Grant/Contract )
BMS100MT ( Other Grant/Funding Number: Bristol Myers Squibb )
First Submitted: September 2, 2010
First Posted: September 3, 2010
Results First Submitted: January 11, 2017
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017