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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lars-Magnus Andersson, Göteborg University
ClinicalTrials.gov Identifier:
NCT01445223
First received: September 28, 2011
Last updated: October 2, 2011
Last verified: October 2011
  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:


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
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
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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 20, 2014