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

September 28, 2011
October 2, 2011
April 2004
December 2009   (final data collection date for primary outcome measure)
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

ITT (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

Complete list of historical versions of study NCT01445223 on ClinicalTrials.gov Archive Site
  • 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
  • Frequency of adverse events and changes in plasma lipids and CD4 cell counts [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
    1. Proportion of treatment discontinuations and changes due to different adverse events.
    2. Changes in CD4+ T-cell count from baseline.
    3. Changes from baseline in plasma lipids.
    4. Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up.
    5. Incidence of abnormal laboratory parameters (Hb, LPK, ASAT, ALAT, ALP, Bilirubin, S-amylas, Creatinin)
  • Adherence to study medication [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
    Proportion of doses taken correctly
Not Provided
Not Provided
 
A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV)
A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Drug: Lopinavir ritonavir
    400mg BD 100mg BD
  • Drug: Atazanavir ritonavir
    300mg QD 100mg QD
  • Drug: Efavirenz
    600mg QD
  • Active Comparator: lopinavir/ritonavir
    400/100 mg BID + 2 NRTIs BID
    Intervention: Drug: Lopinavir ritonavir
  • Active Comparator: atazanavir/ritonavir
    300mg+100mg QD+ 2 NRTI QD
    Intervention: Drug: Atazanavir ritonavir
  • Active Comparator: efavirenz
    600mg QD + 2NRTI QD
    Intervention: Drug: Efavirenz

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01445223
Northiv protocol 3.66
Yes
Lars-Magnus Andersson, Göteborg University
Göteborg University
Not Provided
Principal Investigator: Magnus Gisslén, Professor Goteborg Universitet
Göteborg University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP