This is a prospective, open controlled trial in which HIV-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine. Randomization will be stratified according to the values of nadir CD4 and time of viral suppression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
antiretroviral treatment
Hospital Clínic i Provincial Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Proportion of patients with no treatment failure
* viral failure, defined as two viral loads above 50 copies/ml at least two weeks apart * death * developing new CDC-C events * withdrawing consent * being lost to follow-up * switching assigned treatment for any cause
Time frame: 48 weeks
Proportion of patients with no viral failure
defined as two viral loads above 50 copies/ml. Patients lost to follow-up or changing treatment will not be taken into account for this analysis
Time frame: 48 weeks
Proportion of patients with no therapeutical failure
defined as in the primary outcome but with two viral loads above 400 copies/ml, not 50 as in the primary outcome.
Time frame: 48 weeks
Proportion of patients with no viral failure
defined as two viral loads above 400 copies/ml
Time frame: 48 weeks
Time to viral failure
Two different analysis will be carried out: with 50 copies/ml threshold and with 400 copies/ml threshold
Time frame: 48 weeks
Proportion of patients with blips
Defined as one viral load above 50 and below 400 copies/ml with next viral load below 50 copies/ml
Time frame: 48 weeks
Change from baseline CD4
Time frame: 48 weeks
Lipidic profile change from baseline
Time frame: 48 weeks
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Creatinine clearance change from baseline
Time frame: 48 weeks
Proportion of patients with proximal tubular renal disfunction
Time frame: 48 weeks
Lipodystrophy changes from baseline
evaluated using two questionnaires: lipoatrophy and fat accumulation
Time frame: 48 weeks
Adherence to treatment
Time frame: 48 weeks
Mortality and progression to AIDS
Time frame: 48 weeks
Adverse events per treatment branch
Time frame: 48 weeks
Proportion of patients switching study treatment due to an adverse event
Time frame: 48 weeks
Proportion of serious adverse events related to treatment
Time frame: 48 weeks