Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00389207

First received: October 17, 2006

Last updated: December 9, 2013

Last verified: December 2013

History of Changes

Results First Received: January 13, 2012

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: nevirapine bid Drug: nevirapine qd 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Nevirapine QD	Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID	NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir	Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®

Participant Flow: Overall Study

	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir
STARTED	188 ^[1]	188 ^[2]	193
COMPLETED	125	116	152
NOT COMPLETED	63	72	41
Adverse Event	26	32	10
Protocol Violation	3	1	4
Lost to Follow-up	12	9	7
Withdrawal by Subject	5	7	11
Not specified	17	23	9

[1]	3 patients were randomized to NVP QD but not treated and so not part of the Full Analysis Set (FAS)
[2]	4 patients were randomized to NVP BID but not treated and so are not part of the 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.
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Reporting Groups

	Description
Nevirapine QD	Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID	NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir	ATZ/r on a background of the fixed combination Truvada®
Total	Total of all reporting groups

Baseline Measures

	Nevirapine QD	Nevirapine BID	Atazanvir/Ritonavir	Total
Number of Participants [units: participants]	188	188	193	569
Age [units: years] Mean (Standard Deviation)	38.4 (9.7)	40.0 (10.5)	37.6 (9.5)	38.6 (9.9)
Gender [units: participants]
Female	36	25	31	92
Male	152	163	162	477
Baseline HIV viral load category [units: participants]
Baseline HIV viral load ≤ 100,000 copies/mL	71	71	65	207
Baseline HIV viral load > 100,000 copies/mL	117	117	128	362
Baseline log10 HIV viral load ^[1] [units: log 10 Copies/mL] Mean (Standard Deviation)	5.1 (0.7)	5.1 (0.6)	5.1 (0.7)	5.1 (0.7)
Baseline CD4+ cell count ^[1] [units: Cells/mm^3] Mean (Standard Deviation)	183.3 (95.5)	202.9 (93.6)	193.2 (95.8)	193.2 (95.1)

[1]	185 NVP QD patients, 188 NVP BID patients and 192 ATZ/R patients had data

Outcome Measures

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1. Primary:

Treatment Response at Week 48 [ Time Frame: From baseline to Week 48 ]

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2. Secondary:

Treatment Response at Week 48 (TLOVR Algorithm) [ Time Frame: From baseline to Week 48 ]

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3. Secondary:

Proportion of Patients With VL < 50 Copies/ml [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

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4. Secondary:

Proportion of Patients With VL < 400 Copies/ml [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

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5. Secondary:

Change in CD4+ Count From Baseline [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

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6. Secondary:

Change in Framingham Score From Baseline [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

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7. Secondary:

Change in Mental Health Summary (MHS) Score From Baseline [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

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8. Secondary:

Change in Physical Health Summary (PHS) Score From Baseline [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

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9. Secondary:

Number of Patients Hospitalized [ Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT ]

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10. Secondary:

Non-scheduled Physician Visits [ Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT ]

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11. Secondary:

Genotypic Resistance Associated With Virologic Failure [ Time Frame: From baseline to Week 48 ]

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12. Secondary:

Treatment-emergent AIDS-defining Illness [ Time Frame: From baseline to Week 144 ]

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13. Secondary:

Treatment-emergent AIDS-defining Illness Leading to Death [ Time Frame: From baseline to Week 144 ]

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14. Secondary:

Lipodystrophy [ Time Frame: From baseline to Week 144 ]

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15. Secondary:

Serum Lipid Abnormalities [ Time Frame: From baseline to Week 144 ]

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16. Secondary:

Glycaemic Abnormalities [ Time Frame: From baseline to Week 144 ]

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17. Secondary:

Treatment Response at Week 96 [ Time Frame: From baseline to Week 96 ]

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18. Secondary:

Treatment Response at Week 144 [ Time Frame: From baseline to Week 144 ]

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19. Secondary:

Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144 [ Time Frame: at Week 24, 48, 96, 144 ]

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20. Secondary:

Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144 [ Time Frame: at Week 24, 48, 96, 144 ]

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21. Secondary:

Proportion of Patients With Virologic Failure at Week 48, 96, 144 [ Time Frame: at Week 48, 96, 144 ]

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22. Secondary:

Time to Treatment Response (First Confirmed VL<50 Copies/mL) [ Time Frame: baseline to week 144 ]

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23. Secondary:

Time to Loss of Virologic Response (Rebound) [ Time Frame: Baseline to week 144 ]

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24. Secondary:

Time to Treatment Failure [ Time Frame: baseline to week 144 ]

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25. Secondary:

Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144 [ Time Frame: From baseline to Week 48, 96, 144 ]

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26. Secondary:

Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities [ Time Frame: week 148 ]

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27. Secondary:

Proportion of Patients Reporting Rash of Any Severity [ Time Frame: week 148 ]

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28. Secondary:

Proportion of Patients Reporting Hepatic Events of Any Severity [ Time Frame: week 148 ]

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29. Secondary:

Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity [ Time Frame: week 148 ]

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30. Secondary:

Change of Cholesterol Values From Baseline to Week 48, 96, 144 [ Time Frame: baseline to week 48, 96, 144 ]

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31. Secondary:

Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144 [ Time Frame: baseline to week 48, 96, 144 ]

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32. Secondary:

Change of hsCRP From Baseline to Week 48, 96, 144 [ Time Frame: baseline to week 48, 96, 144 ]

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33. Secondary:

Change of Total Triglycerides From Baseline to Week 48, 96, 144 [ Time Frame: baseline to week 48, 96, 144 ]

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34. Secondary:

Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144 [ Time Frame: baseline to week 48, 96, 144 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Seclén E, Soriano V, González MM, Martín-Carbonero L, Gellermann H, Distel M, Kadus W, Poveda E. Impact of baseline HIV-1 tropism on viral response and CD4 cell count gains in HIV-infected patients receiving first-line antiretroviral therapy. J Infect Dis. 2011 Jul 1;204(1):139-44. doi: 10.1093/infdis/jir218.

Soriano V, Arastéh K, Migrone H, Lutz T, Opravil M, Andrade-Villanueva J, Antunes F, Di Perri G, Podzamczer D, Taylor S, Domingo P, Gellermann H, de Rossi L; ARTEN investigators. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther. 2011;16(3):339-48. doi: 10.3851/IMP1745.

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00389207 History of Changes
Other Study ID Numbers:	1100.1470 2005-004330-40 ( EudraCT Number: EudraCT )
Study First Received:	October 17, 2006
Results First Received:	January 13, 2012
Last Updated:	December 9, 2013
Health Authority:	Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) Germany: Federal Institute for Drugs and Medical Devices Great Britain: MHRA Italy: Comitato Etico dell'Azienda Osp. Riuniti di Bergamo - Bergamo Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency, Bucharest Spain: Agencia Espanola del Medicamento y Productos Sanitarios Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products)

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