Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00552240
First received: September 28, 2007
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: March 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: tenofovir DF 300 mg QD
Drug: emtricitabine 200 mg QD
Drug: Nevirapine 200 mg BID
Drug: Atazanavir 300 mg
Drug: Ritonavir 100 mg

  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
Patients were recruited from 28 Sep 2007 through 23 Mar 2009 at 18 sites throughout the US. The sites were comprised of medical centers or private practice physicians.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a 28 day screening period where a genotype report was run. If patients were resistant to any of the study medication, they were not to be randomized into the study. Patients also needed to meet all inclusion/exclusion criteria in order to be eligible. 154 patients were enrolled but 2 were not treated, leaving 152 in full analysis set.

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Participant Flow:   Overall Study
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
STARTED     75 [1]   77 [1]
COMPLETED     51     59  
NOT COMPLETED     24     18  
Adverse Event                 9                 9  
Protocol Violation                 1                 1  
Lost to Follow-up                 5                 6  
Withdrawal by Subject                 2                 2  
Lack of Efficacy                 6                 0  
not specified                 1                 0  
[1] Number in Full Analysis Set (FAS)



  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.
Full Analysis Set (FAS)

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Total Total of all reporting groups

Baseline Measures
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada     Total  
Number of Participants  
[units: participants]
  75     77     152  
Age  
[units: years]
Mean ± Standard Deviation
  37.7  ± 10.4     35.9  ± 9.7     36.8  ± 10.1  
Gender  
[units: participants]
     
Female     10     6     16  
Male     65     71     136  
Log10 HIV viral load  
[units: copies/mL]
Mean ± Standard Deviation
  4.9  ± 0.8     4.9  ± 0.7     4.9  ± 0.8  
CD4+ count  
[units: cells/mm^3]
Mean ± Standard Deviation
  178.9  ± 105.3     183.5  ± 111.3     181.2  ± 108.0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Virologic Response (VR)   [ Time Frame: baseline to week 48 ]

2.  Secondary:   Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: baseline to week 48 ]

3.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48   [ Time Frame: baseline to week 48 ]

4.  Secondary:   Number of Participants With Virologic Success (FDA Definition)   [ Time Frame: baseline to week 48 ]

5.  Secondary:   Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants   [ Time Frame: baseline to week 48 ]

6.  Secondary:   Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml   [ Time Frame: baseline to week 48 ]

7.  Secondary:   Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response   [ Time Frame: baseline to week 24 and week 48 ]

8.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment   [ Time Frame: baseline to week 2 ]

9.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment   [ Time Frame: baseline to week 4 ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Measure Description Results within time windows, patients on-treatment
Time Frame baseline to week 4  
Safety Issue No  

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.
All treated patients

Reporting Groups
  Description
Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Measured Values
    Nevirapine (NVP) Plus Truvada     Atazanavir Plus Ritonavir (ATV/r) Plus Truvada  
Number of Participants Analyzed  
[units: participants]
  75     77  
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment  
[units: Participants]
   
HIV viral load < 50 copies/ml     12     10  
HIV viral load ≥ 50 copies/ml     53     62  
Missing data     10     5  

No statistical analysis provided for Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment



10.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment   [ Time Frame: baseline to week 6 ]

11.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment   [ Time Frame: baseline to week 8 ]

12.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment   [ Time Frame: baseline to week 12 ]

13.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment   [ Time Frame: baseline to week 24 ]

14.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment   [ Time Frame: baseline to week 36 ]

15.  Secondary:   Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment   [ Time Frame: baseline to week 48 ]

16.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment   [ Time Frame: baseline to week 2 ]

17.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment   [ Time Frame: baseline to week 4 ]

18.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment   [ Time Frame: baseline to week 6 ]

19.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment   [ Time Frame: baseline to week 8 ]

20.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment   [ Time Frame: baseline to week 12 ]

21.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment   [ Time Frame: baseline to week 24 ]

22.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment   [ Time Frame: baseline to week 36 ]

23.  Secondary:   Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment   [ Time Frame: baseline to week 48 ]

24.  Secondary:   Number of Patients With Virologic Rebound to >400 Copies/ml   [ Time Frame: baseline to week 48 ]

25.  Secondary:   AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death   [ Time Frame: baseline to week 48 ]

26.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 2.   [ Time Frame: baseline to week 2 ]

27.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 4.   [ Time Frame: baseline to week 4 ]

28.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 6.   [ Time Frame: baseline to week 6 ]

29.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 8.   [ Time Frame: baseline to week 8 ]

30.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 12.   [ Time Frame: baseline to week 12 ]

31.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 24.   [ Time Frame: baseline to week 24 ]

32.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 36.   [ Time Frame: baseline to week 36 ]

33.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 48.   [ Time Frame: baseline to week 48 ]

34.  Secondary:   Change in Fasting Plasma Total Cholesterol Level   [ Time Frame: baseline to week 48 ]

35.  Secondary:   Change in Fasting Plasma Triglycerides Level   [ Time Frame: baseline to week 48 ]

36.  Secondary:   Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level   [ Time Frame: baseline to week 48 ]

37.  Secondary:   Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level   [ Time Frame: baseline to week 48 ]

38.  Secondary:   Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio   [ Time Frame: baseline to week 48 ]

39.  Secondary:   Change in Framingham Score   [ Time Frame: baseline to week 48 ]

40.  Secondary:   Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group   [ Time Frame: baseline to week 48 ]

41.  Secondary:   Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48   [ Time Frame: baseline to week 48 ]

42.  Secondary:   Percentage Adherence by Pill Count   [ Time Frame: baseline to week 48 ]

43.  Secondary:   Number of Participants With Genotypic Resistance at the Time of Virologic Failure.   [ Time Frame: baseline to week 48 ]

44.  Secondary:   Incidence of Patients With AIDS Progression at Each Visit   [ Time Frame: baseline to week 52 ]

45.  Secondary:   Proportion of Patients Reporting CNS Side Effects of Any Severity   [ Time Frame: baseline to week 52 ]

46.  Secondary:   Proportion of Patients Reporting Hepatic Events of Any Severity   [ Time Frame: baseline to week 52 ]

47.  Secondary:   Proportion of Patients Reporting Rash of Any Severity   [ Time Frame: baseline to week 52 ]

48.  Secondary:   Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities   [ Time Frame: baseline to week 52 ]


  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
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  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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00552240     History of Changes
Other Study ID Numbers: 1100.1512
Study First Received: September 28, 2007
Results First Received: March 16, 2011
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration