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

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ClinicalTrials.gov Identifier: NCT01445223
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : October 4, 2011
Sponsor:
Information provided by (Responsible Party):
Lars-Magnus Andersson, Göteborg University

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Drug: Lopinavir ritonavir Drug: Atazanavir ritonavir Drug: Efavirenz Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)
Study Start Date : April 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Intention to treat (ITT)/time to loss of virological response (TLOVR) [ Time Frame: 144 weeks ]
    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 :
  1. Frequency of abnormal laboratory parameters [ Time Frame: 144 weeks ]
    Incidence of abnormal laboratory parameters at follow-up

  2. Adherence to study medication [ Time Frame: 144 weeks ]
    Proportion of doses taken correctly

  3. Frequency of adverse events [ Time Frame: 144 weeks ]
    Proportion of treatment discontinuations and changes due to different adverse events

  4. Changes in CD4 cell counts [ Time Frame: 144 weeks ]
    Changes in CD4+ T-cell count from baseline

  5. Changes in plasma lipids [ Time Frame: 144 weeks ]
    Changes from baseline in plasma lipids

  6. Frequency of hyperlipidemia [ Time Frame: 144 weeks ]
    Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
Goteborg University  This link exits the ClinicalTrials.gov site

Publications of Results:

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
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by Lars-Magnus Andersson, 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