A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV) - Full Text View

Purpose

The present study aims to compare efficacy, side-effects, and treatment adherence of three different treatment regimens given to antiretroviral naïve HIV-1 infected patients. Treatment will be initiated in accordance with the Swedish National Guidelines. In the twice daily (BID) arm (1), which could be considered as a standard regimen at present, lopinavir/ritonavir, is co-administrated with 2 nucleoside reverse transcriptase inhibitors (NRTIs) administrated BID. The first once daily (QD) arm (2) combines the protease inhibitor (PI) atazanavir/ritonavir with 2 NRTIs administrated QD, and in the second QD arm (3), the non nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz is combined with 2 NRTIs administrated QD. All drugs used in the study are licensed in the participating countries and patients will be followed as in clinical practice. Patients could optionally, after informed consent, be followed with additional measurements of HIV-1 RNA after 1, 2, and 3 weeks of treatment to asses the kinetics of viral decline after initiation of treatment.

Condition	Intervention	Phase
HIV	Drug: Lopinavir ritonavir Drug: Atazanavir ritonavir Drug: Efavirenz	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Efavirenz Ritonavir Lopinavir Atazanavir Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:

Intention to treat (ITT)/time to loss of virological response (TLOVR) [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
1. Virological failure (see 5.5.2 for definition)
2. Treatment interruption or change of study treatment due to side-effects
3. Treatment interruption or change of study treatment due to any other reason
4. Missed to follow-up
1. HIV-1 RNA >50 copies/ml in two consecutive measurements from week 24 and on 2. any rise in HIV-1 RNA >50 copies/ml in two consecutive measurements after viral load <50 copies/ml has been reached 3. HIV-1 RNA never <50 copies/ml after week 24

Secondary Outcome Measures:

Frequency of abnormal laboratory parameters [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
Incidence of abnormal laboratory parameters at follow-up
Adherence to study medication [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
Proportion of doses taken correctly
Frequency of adverse events [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
Proportion of treatment discontinuations and changes due to different adverse events
Changes in CD4 cell counts [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
Changes in CD4+ T-cell count from baseline
Changes in plasma lipids [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
Changes from baseline in plasma lipids
Frequency of hyperlipidemia [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up


Enrollment:	242
Study Start Date:	April 2004
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: lopinavir/ritonavir 400/100 mg BID + 2 NRTIs BID	Drug: Lopinavir ritonavir 400mg BD 100mg BD
Active Comparator: atazanavir/ritonavir 300mg+100mg QD+ 2 NRTI QD	Drug: Atazanavir ritonavir 300mg QD 100mg QD
Active Comparator: efavirenz 600mg QD + 2NRTI QD	Drug: Efavirenz 600mg QD

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, aged 16 years of age
HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
Ability to understand and provide informed consent
Indication for antiretroviral treatment
Antiretroviral naïve
All clinical laboratory values not clinically significant

Exclusion Criteria:

Subjects being pregnant
Women of childbearing potential not practicing birth control
Subjects with renal failure requiring dialysis
Drug interactions with any of the study drugs that are not manageable
Resistance to any of the study drugs

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445223

Locations


Sweden
Department of Infectious Diseases
Goteborg, Sweden, S-41685

Sponsors and Collaborators

Göteborg University

Investigators


Principal Investigator:	Magnus Gisslén, Professor	Goteborg Universitet

More Information

Additional Information:

Goteborg University This link exits the ClinicalTrials.gov site

Publications:

Edén A, Andersson LM, Andersson O, Flamholc L, Josephson F, Nilsson S, Ormaasen V, Svedhem V, Säll C, Sönnerborg A, Tunbäck P, Gisslén M. Differential effects of efavirenz, lopinavir/r, and atazanavir/r on the initial viral decay rate in treatment naïve HIV-1-infected patients. AIDS Res Hum Retroviruses. 2010 May;26(5):533-40. doi: 10.1089/aid.2009.0177.

Josephson F, Andersson MC, Flamholc L, Gisslén M, Hagberg L, Ormaasen V, Sönnerborg A, Vesterbacka J, Böttiger Y. The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naïve HIV-1 infected patients. Eur J Clin Pharmacol. 2010 Apr;66(4):349-57. doi: 10.1007/s00228-009-0763-z. Epub 2009 Dec 5.

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

Vesterbacka J, Nowak P, Barqasho B, Abdurahman S, Nyström J, Nilsson S, Funaoka H, Kanda T, Andersson LM, Gisslèn M, Sönnerborg A. Kinetics of microbial translocation markers in patients on efavirenz or lopinavir/r based antiretroviral therapy. PLoS One. 2013;8(1):e55038. doi: 10.1371/journal.pone.0055038. Epub 2013 Jan 28.


Responsible Party:	Lars-Magnus Andersson, Principal Investigator, Göteborg University
ClinicalTrials.gov Identifier:	NCT01445223 History of Changes
Other Study ID Numbers:	Northiv protocol 3.66
Study First Received:	September 28, 2011
Last Updated:	October 2, 2011
Health Authority:	Sweden: Swedish medical agency (Lakemedelsverket)

Keywords provided by Göteborg University:


HIV Antiretroviral therapy efavirenz	lopinavir atazanavir randomised controlled clinical trial

Additional relevant MeSH terms:


Ritonavir Lopinavir Atazanavir Sulfate Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents	Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on September 26, 2016