NCT01445223

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Lopinavir ritonavir	400mg BD 100mg BD
DRUG	Atazanavir ritonavir	300mg QD 100mg QD
DRUG	Efavirenz	600mg QD

Timeline

• Start date: 2004-04-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2011-10-03
• Last updated: 2011-10-04

Locations

1 site across 1 country: Sweden