Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months
Hospital del Mar
Bercelona, Barcelona, Spain
Hospital Universitary de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
plasma viral load <40 copies/mL
HIV Plasma Viral Load \<40 copies/ml at week 48.
Time frame: Week 48
Stability in the plasma levels of Lopinavir/ritonavir during all study visits
Determination of plasma concentrations of the study drug at weeks 4, 8, 12, 16, 24, 36 and 48
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
Tolerability
Possible Adverse Events will be collected in all study visits and laboratory tests will also be performed in all study visits (weeks 4, 8, 12, 16, 24, 36 and 48)
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
Adherence
Medication adherence will be evaluated in all the study visits after making a reconciliation of the medication dispensed and returned by the patients
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
Satisfaction
Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ)
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48
- Efficacy in CSF
\- In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment)
Time frame: At least 4 weeks on study treatment
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