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

NCT ID: NCT01445223

Last Updated: 2011-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lopinavir/ritonavir

400/100 mg BID + 2 NRTIs BID

Group Type ACTIVE_COMPARATOR

Lopinavir ritonavir

Intervention Type DRUG

400mg BD 100mg BD

atazanavir/ritonavir

300mg+100mg QD+ 2 NRTI QD

Group Type ACTIVE_COMPARATOR

Atazanavir ritonavir

Intervention Type DRUG

300mg QD 100mg QD

efavirenz

600mg QD + 2NRTI QD

Group Type ACTIVE_COMPARATOR

Efavirenz

Intervention Type DRUG

600mg QD

Interventions

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Lopinavir ritonavir

400mg BD 100mg BD

Intervention Type DRUG

Atazanavir ritonavir

300mg QD 100mg QD

Intervention Type DRUG

Efavirenz

600mg QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Lars-Magnus Andersson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magnus Gisslén, Professor

Role: PRINCIPAL_INVESTIGATOR

Goteborg Universitet

Locations

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Department of Infectious Diseases

Gothenburg, Goteborg, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 20455766 (View on PubMed)

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.

Reference Type RESULT
PMID: 19967342 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23383047 (View on PubMed)

Related Links

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http://www.sahlgrenska.gu.se/

Goteborg University

Other Identifiers

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Northiv protocol 3.66

Identifier Type: -

Identifier Source: org_study_id