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

Study Overview
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Drug: Lopinavir ritonavir
* Drug: Atazanavir ritonavir
* Drug: Efavirenz


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lopinavir/ritonavir<br>400/100 mg BID + 2 NRTIs BID | Drug: Lopinavir ritonavir<br>* 400mg BD 100mg BD<br>|
| Active Comparator: atazanavir/ritonavir<br>300mg+100mg QD+ 2 NRTI QD | Drug: Atazanavir ritonavir<br>* 300mg QD 100mg QD<br>|
| Active Comparator: efavirenz<br>600mg QD + 2NRTI QD | Drug: Efavirenz<br>* 600mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Antiretroviral therapy, efavirenz, lopinavir, atazanavir, randomised controlled clinical trial