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Completed

NCT Number: NCT01445223

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

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.

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Key information

Conditions

HIV

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Infectious Diseases

Gothenburg, Goteborg, S-41685, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lopinavir ritonavir

Drug

400mg BD 100mg BD

Atazanavir ritonavir

Drug

300mg QD 100mg QD

Efavirenz

Drug

600mg QD

Primary outcomes

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

    Time frame: 144 weeks

    • Virological failure (see 5.5.2 for definition)
    • Treatment interruption or change of study treatment due to side-effects
    • Treatment interruption or change of study treatment due to any other reason
    • Missed to follow-up
    • 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 3, 2011
Registry last updated
Oct 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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