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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445223
• Other study ID #: Northiv protocol 3.66
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2011
• Last updated: October 2, 2011
• Start date: April 2004
• Est. completion date: December 2009

Study information

• Verified date: October 2011
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish medical agency (Lakemedelsverket)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Lopinavir ritonavir
400mg BD 100mg BD
• Atazanavir ritonavir
300mg QD 100mg QD
• Efavirenz
600mg QD

Locations

Country	Name	City	State
Sweden	Department of Infectious Diseases	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Edén A, Andersson LM, Andersson O, Flamholc L, Josephson F, Nilsson S, Ormaasen V, Svedhem V, Säll C, Sönnerborg A, Tunbäck P, Gisslén M. Differential effects of efavirenz, lopinavir/r, and atazanavir/r on the initial viral decay rate in treatment naïve H — View Citation

Josephson F, Andersson MC, Flamholc L, Gisslén M, Hagberg L, Ormaasen V, Sönnerborg A, Vesterbacka J, Böttiger Y. The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naïve HIV-1 infected — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention to treat (ITT)/time to loss of virological response (TLOVR)	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	144 weeks	Yes
Secondary	Frequency of abnormal laboratory parameters	Incidence of abnormal laboratory parameters at follow-up	144 weeks	Yes
Secondary	Adherence to study medication	Proportion of doses taken correctly	144 weeks	Yes
Secondary	Frequency of adverse events	Proportion of treatment discontinuations and changes due to different adverse events	144 weeks	Yes
Secondary	Changes in CD4 cell counts	Changes in CD4+ T-cell count from baseline	144 weeks	Yes
Secondary	Changes in plasma lipids	Changes from baseline in plasma lipids	144 weeks	Yes
Secondary	Frequency of hyperlipidemia	Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up	144 weeks	Yes

External Links

•   Goteborg University