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

Sponsor

Göteborg University (Other)

Overall Status

Completed

CT.gov ID

NCT01445223

Collaborator

(none)

242

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Drug: Lopinavir ritonavir Drug: Atazanavir ritonavir Drug: Efavirenz	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

242 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lopinavir/ritonavir 400/100 mg BID + 2 NRTIs BID	Drug: Lopinavir ritonavir 400mg BD 100mg BD
Active Comparator: atazanavir/ritonavir 300mg+100mg QD+ 2 NRTI QD	Drug: Atazanavir ritonavir 300mg QD 100mg QD
Active Comparator: efavirenz 600mg QD + 2NRTI QD	Drug: Efavirenz 600mg QD

Arm

Intervention/Treatment

Active Comparator: lopinavir/ritonavir

400/100 mg BID + 2 NRTIs BID

Drug: Lopinavir ritonavir

400mg BD 100mg BD

Active Comparator: atazanavir/ritonavir

300mg+100mg QD+ 2 NRTI QD

Drug: Atazanavir ritonavir

300mg QD 100mg QD

Active Comparator: efavirenz

600mg QD + 2NRTI QD

Drug: Efavirenz

600mg QD

Outcome Measures

Primary Outcome Measures

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

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