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

NCT01445223 | Completed Phase 4 DMC

• 1 other identifier: Northiv protocol 3.66
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV; Antiretroviral therapy; efavirenz; lopinavir; atazanavir; randomised controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• Intention to treat (ITT)/time to loss of virological response (TLOVR)

  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

  144 weeks

Secondary Outcomes (6)

• Frequency of abnormal laboratory parameters

  144 weeks

• Adherence to study medication

  144 weeks

• Frequency of adverse events

  144 weeks

• Changes in CD4 cell counts

  144 weeks

• Changes in plasma lipids

  144 weeks

Study Arms (3)

lopinavir/ritonavir

ACTIVE COMPARATOR

400/100 mg BID + 2 NRTIs BID

Drug: Lopinavir ritonavir

atazanavir/ritonavir

ACTIVE COMPARATOR

300mg+100mg QD+ 2 NRTI QD

Drug: Atazanavir ritonavir

efavirenz

ACTIVE COMPARATOR

600mg QD + 2NRTI QD

Drug: Efavirenz

Interventions

Lopinavir ritonavir DRUG

400mg BD 100mg BD

lopinavir/ritonavir

Atazanavir ritonavir DRUG

300mg QD 100mg QD

atazanavir/ritonavir

Efavirenz DRUG

600mg QD

efavirenz

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Department of Infectious Diseases

Gothenburg, Goteborg, S-41685, Sweden

Location

Related Publications (3)

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

  PMID: 20455766 RESULT

• Josephson F, Andersson MC, Flamholc L, Gisslen M, Hagberg L, Ormaasen V, Sonnerborg A, Vesterbacka J, Bottiger Y. The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naive 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.

  PMID: 19967342 RESULT

• Vesterbacka J, Nowak P, Barqasho B, Abdurahman S, Nystrom J, Nilsson S, Funaoka H, Kanda T, Andersson LM, Gisslen M, Sonnerborg 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.

  PMID: 23383047 DERIVED

Related Links

• Goteborg University

MeSH Terms

Interventions

Lopinavir; atazanavir, ritonavir drug combination; efavirenz

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Magnus Gisslén, Professor

  Goteborg Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 3, 2011
• Study Start: April 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

SE (1)