A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV)
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ClinicalTrials.gov Identifier: NCT01445223 |
Recruitment Status
:
Completed
First Posted
: October 3, 2011
Last Update Posted
: October 4, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Lopinavir ritonavir Drug: Atazanavir ritonavir Drug: Efavirenz | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 2004 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

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
|
- Intention to treat (ITT)/time to loss of virological response (TLOVR) [ Time Frame: 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
- Frequency of abnormal laboratory parameters [ Time Frame: 144 weeks ]Incidence of abnormal laboratory parameters at follow-up
- Adherence to study medication [ Time Frame: 144 weeks ]Proportion of doses taken correctly
- Frequency of adverse events [ Time Frame: 144 weeks ]Proportion of treatment discontinuations and changes due to different adverse events
- Changes in CD4 cell counts [ Time Frame: 144 weeks ]Changes in CD4+ T-cell count from baseline
- Changes in plasma lipids [ Time Frame: 144 weeks ]Changes from baseline in plasma lipids
- Frequency of hyperlipidemia [ Time Frame: 144 weeks ]Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445223
Sweden | |
Department of Infectious Diseases | |
Goteborg, Sweden, S-41685 |
Principal Investigator: | Magnus Gisslén, Professor | Goteborg Universitet |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lars-Magnus Andersson, Principal Investigator, Göteborg University |
ClinicalTrials.gov Identifier: | NCT01445223 History of Changes |
Other Study ID Numbers: |
Northiv protocol 3.66 |
First Posted: | October 3, 2011 Key Record Dates |
Last Update Posted: | October 4, 2011 |
Last Verified: | October 2011 |
Keywords provided by Lars-Magnus Andersson, Göteborg University:
HIV Antiretroviral therapy efavirenz |
lopinavir atazanavir randomised controlled clinical trial |
Additional relevant MeSH terms:
Ritonavir Lopinavir Atazanavir Sulfate Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |
Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |