A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Lopinavir ritonavir Drug: Atazanavir ritonavir Drug: Efavirenz |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study) |
- Intention to treat (ITT)/time to loss of virological response (TLOVR) [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]Incidence of abnormal laboratory parameters at follow-up
- Adherence to study medication [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]Proportion of doses taken correctly
- Frequency of adverse events [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]Proportion of treatment discontinuations and changes due to different adverse events
- Changes in CD4 cell counts [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]Changes in CD4+ T-cell count from baseline
- Changes in plasma lipids [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]Changes from baseline in plasma lipids
- Frequency of hyperlipidemia [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up
| Enrollment: | 242 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
Additional Information:
Publications:
Additional 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 |
| Study First Received: | September 28, 2011 |
| Last Updated: | October 2, 2011 |
| Health Authority: | Sweden: Swedish medical agency (Lakemedelsverket) |
Keywords provided by Göteborg University:
|
HIV Antiretroviral therapy efavirenz |
lopinavir atazanavir randomised controlled clinical trial |
Additional relevant MeSH terms:
|
Ritonavir Lopinavir Atazanavir Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013