HIVPhase 4NCT01445223
A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV)
A Phase 4 study testing Lopinavir ritonavir, Atazanavir ritonavir and Efavirenz in people with HIV, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Lopinavir ritonavir, Atazanavir ritonavir and Efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2004to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)
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
- Being tested
- Lopinavir ritonavir, Atazanavir ritonavir, Efavirenz
- Keywords
- HIV, Antiretroviral therapy, efavirenz, lopinavir, atazanavir, randomised controlled clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir ritonavirDrug
400mg BD 100mg BD
Atazanavir ritonavirDrug
300mg QD 100mg QD
EfavirenzDrug
600mg QD
| Study group | Role | What they receive |
|---|---|---|
| lopinavir/ritonavir | Active comparator | 400/100 mg BID + 2 NRTIs BID Receives: Drug: Lopinavir ritonavir |
| atazanavir/ritonavir | Active comparator | 300mg+100mg QD+ 2 NRTI QD Receives: Drug: Atazanavir ritonavir |
| efavirenz | Active comparator | 600mg QD + 2NRTI QD Receives: Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: 144 weeks
Secondary outcomes (6)
Frequency of abnormal laboratory parameters
Incidence of abnormal laboratory parameters at follow-up
Measured: 144 weeks
Adherence to study medication
Proportion of doses taken correctly
Measured: 144 weeks
Frequency of adverse events
Proportion of treatment discontinuations and changes due to different adverse events
Measured: 144 weeks
Changes in CD4 cell counts
Changes in CD4+ T-cell count from baseline
Measured: 144 weeks
Changes in plasma lipids
Changes from baseline in plasma lipids
Measured: 144 weeks
Frequency of hyperlipidemia
Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up
Measured: 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startApr 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars-Magnus Andersson, Göteborg University
- Investigators
- Magnus Gisslén, Professor, Principal investigator, Goteborg Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445223
- Sponsor's protocol ID
- Northiv protocol 3.66
- Status last verified
- Oct 2011
- First submitted
- 28 Sep 2011
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eden A, Andersson LM, Andersson O, Flamholc L, Josephson F, Nilsson S, Ormaasen V, Svedhem V, Sall C, Sonnerborg A, Tunback P, Gisslen M. Differential effects of efavirenz, lopinavir/r, and atazanavir/r on the initial viral decay rate in treatment naive HIV-1-infected patients. AIDS Res Hum Retroviruses. 2010 May;26(5):533-40. doi: 10.1089/aid.2009.0177.
PubMed 20455766Josephson F, Andersson MC, Flamholc L, Gisslen M, Hagberg L, Ormaasen V, Sonnerborg A, Vesterbacka J, Bottiger Y. The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naive HIV-1 infected patients. Eur J Clin Pharmacol. 2010 Apr;66(4):349-57. doi: 10.1007/s00228-009-0763-z. Epub 2009 Dec 5.
PubMed 19967342Vesterbacka J, Nowak P, Barqasho B, Abdurahman S, Nystrom J, Nilsson S, Funaoka H, Kanda T, Andersson LM, Gisslen M, Sonnerborg A. Kinetics of microbial translocation markers in patients on efavirenz or lopinavir/r based antiretroviral therapy. PLoS One. 2013;8(1):e55038. doi: 10.1371/journal.pone.0055038. Epub 2013 Jan 28.
PubMed 23383047
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)
- ClinicalTrials.gov ID
- NCT01445223
- Acronym / sponsor ID
- Northiv protocol 3.66
- Conditions
- HIV
- Keywords
- HIV, Antiretroviral therapy, efavirenz, lopinavir, atazanavir, randomised controlled clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lopinavir/ritonavir | Active comparator | Drug: Lopinavir ritonavir400/100 mg BID + 2 NRTIs BID |
| atazanavir/ritonavir | Active comparator | Drug: Atazanavir ritonavir300mg+100mg QD+ 2 NRTI QD |
| efavirenz | Active comparator | Drug: Efavirenz600mg QD + 2NRTI QD |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir ritonavir400mg BD 100mg BD | Drug | lopinavir/ritonavir |
| Atazanavir ritonavir300mg QD 100mg QD | Drug | atazanavir/ritonavir |
| Efavirenz600mg QD | Drug | efavirenz |
Primary outcome
Intention to treat (ITT)/time to loss of virological response (TLOVR)
Time frame: 144 weeks
1. Virological failure (see 5.5.2 for definition) 2. Treatment interruption or change of study treatment due to side-effects 3. Treatment interruption or change of study treatment due to any other reason 4. 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
6 secondary outcomes
Frequency of abnormal laboratory parameters
Time frame: 144 weeks
Adherence to study medication
Time frame: 144 weeks
Frequency of adverse events
Time frame: 144 weeks
Changes in CD4 cell counts
Time frame: 144 weeks
Changes in plasma lipids
Time frame: 144 weeks
Frequency of hyperlipidemia
Time frame: 144 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
- Results publication: PubMed 20455766Eden A, Andersson LM, Andersson O, Flamholc L, Josephson F, Nilsson S, Ormaasen V, Svedhem V, Sall C, Sonnerborg A, Tunback P, Gisslen M. Differential effects of efavirenz, lopinavir/r, and atazanavir/r on the initial viral decay rate in treatment naive HIV-1-infected patients. AIDS Res Hum Retroviruses. 2010 May;26(5):533-40. doi: 10.1089/aid.2009.0177.
- Results publication: PubMed 19967342Josephson F, Andersson MC, Flamholc L, Gisslen M, Hagberg L, Ormaasen V, Sonnerborg A, Vesterbacka J, Bottiger Y. The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naive HIV-1 infected patients. Eur J Clin Pharmacol. 2010 Apr;66(4):349-57. doi: 10.1007/s00228-009-0763-z. Epub 2009 Dec 5.
- Derived from this study: PubMed 23383047Vesterbacka J, Nowak P, Barqasho B, Abdurahman S, Nystrom J, Nilsson S, Funaoka H, Kanda T, Andersson LM, Gisslen M, Sonnerborg A. Kinetics of microbial translocation markers in patients on efavirenz or lopinavir/r based antiretroviral therapy. PLoS One. 2013;8(1):e55038. doi: 10.1371/journal.pone.0055038. Epub 2013 Jan 28.
- Goteborg UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Gisslén, Professor principal investigator
Goteborg Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lopinavir ritonavir, Atazanavir ritonavir and Efavirenz in people with HIV, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to treat (ITT)/time to loss of virological response (TLOVR) (time frame: 144 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445223, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.