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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lopinavir/ritonavir | Active Comparator | 400/100 mg BID + 2 NRTIs BID |
|
| atazanavir/ritonavir | Active Comparator | 300mg+100mg QD+ 2 NRTI QD |
|
| efavirenz | Active Comparator | 600mg QD + 2NRTI QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir ritonavir | Drug | 400mg BD 100mg BD |
| |
| Atazanavir ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| Intention to treat (ITT)/time to loss of virological response (TLOVR) |
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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Gisslén, Professor | Goteborg Universitet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases | Gothenburg | Goteborg | S-41685 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20455766 | Result | 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. | |
| 19967342 |
| Label | URL |
|---|---|
| Goteborg University | View source |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| C000718687 | atazanavir, ritonavir drug combination |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
300mg QD 100mg QD |
|
| Efavirenz | Drug | 600mg QD |
|
| 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 |
| Josephson 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. |
| 23383047 | Derived | Vesterbacka 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. |