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

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: Atazanavir ritonavir; Drug: Lopinavir ritonavir; Drug: Efavirenz

• Registration Number: NCT01445223
• Lead Sponsor: Göteborg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-30
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-02
• Study First Posted: 2011-10-03
• Last Update Posted: 2011-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atazanavir/ritonavir	Atazanavir ritonavir	300mg+100mg QD+ 2 NRTI QD
lopinavir/ritonavir	Lopinavir ritonavir	400/100 mg BID + 2 NRTIs BID
efavirenz	Efavirenz	600mg QD + 2NRTI QD

Primary Outcome Measures

Name	Time	Method
Intention to treat (ITT)/time to loss of virological response (TLOVR)	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

Name	Time	Method
Frequency of abnormal laboratory parameters	144 weeks	Incidence of abnormal laboratory parameters at follow-up
Adherence to study medication	144 weeks	Proportion of doses taken correctly
Frequency of adverse events	144 weeks	Proportion of treatment discontinuations and changes due to different adverse events
Changes in CD4 cell counts	144 weeks	Changes in CD4+ T-cell count from baseline
Changes in plasma lipids	144 weeks	Changes from baseline in plasma lipids
Frequency of hyperlipidemia	144 weeks	Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up

Trial Locations

Locations (1)

Department of Infectious Diseases; 🇸🇪 Goteborg, Sweden