Clinical trial NCT01445223: A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV)
Official title: A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: HIV
Antiretroviral therapy
efavirenz
lopinavir
atazanavir
randomised controlled clinical trial
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 242
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Intention to treat (ITT)/time to loss of virological response (TLOVR)
timeFrame: 144 weeks
Secondary outcomes:
measure: Frequency of abnormal laboratory parameters
timeFrame: 144 weeks
measure: Adherence to study medication
timeFrame: 144 weeks
measure: Frequency of adverse events
timeFrame: 144 weeks
measure: Changes in CD4 cell counts
timeFrame: 144 weeks
measure: Changes in plasma lipids
timeFrame: 144 weeks
measure: Frequency of hyperlipidemia
timeFrame: 144 weeks
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Department of Infectious Diseases
Study officials:
affiliation: Goteborg Universitet
name: Magnus Gisslén, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.