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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
400mg BD 100mg BD
300mg QD 100mg QD
600mg QD
Department of Infectious Diseases
Gothenburg, Goteborg, Sweden
Intention to treat (ITT)/time to loss of virological response (TLOVR)
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
Time frame: 144 weeks
Frequency of abnormal laboratory parameters
Incidence of abnormal laboratory parameters at follow-up
Time frame: 144 weeks
Adherence to study medication
Proportion of doses taken correctly
Time frame: 144 weeks
Frequency of adverse events
Proportion of treatment discontinuations and changes due to different adverse events
Time frame: 144 weeks
Changes in CD4 cell counts
Changes in CD4+ T-cell count from baseline
Time frame: 144 weeks
Changes in plasma lipids
Changes from baseline in plasma lipids
Time frame: 144 weeks
Frequency of hyperlipidemia
Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up
Time frame: 144 weeks
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