HIV
Conditions
Keywords
HIV, Antiretroviral therapy, efavirenz, lopinavir, atazanavir, randomised controlled clinical trial
Brief 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. 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.
Interventions
400mg BD 100mg BD
DRUGAtazanavir ritonavir
300mg QD 100mg QD
DRUGEfavirenz
600mg QD
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention to treat (ITT)/time to loss of virological response (TLOVR) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to study medication | 144 weeks | Proportion of doses taken correctly |
| Frequency of adverse events | 144 weeks | Proportion of treatment discontinuations and changes due to different adverse events |
| Frequency of abnormal laboratory parameters | 144 weeks | Incidence of abnormal laboratory parameters at follow-up |
| Changes in plasma lipids | 144 weeks | Changes from baseline in plasma lipids |
| Frequency of hyperlipidemia | 144 weeks | Incidence of hypercholesterolemia and hypertriglyceridemia at baseline and follow-up |
| Changes in CD4 cell counts | 144 weeks | Changes in CD4+ T-cell count from baseline |
Countries
Sweden
Outcome results
None listed