Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

Conditions
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HIV

Intervention / Treatment
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* Drug: Lopinavir/ritonavir 800 mg / 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18, HIV positive Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months Undetectable viral load (<40 copies/ml) during the last 6 months Patients that accept participation in the study and sign the Informed Consent Form Childbearing females with negative pregnancy tests and using appropriate contraceptive measures Exclusion Criteria: Opportunistic disease, cancer or any other active disease with specific treatment Active addiction to illegal drugs or active use of psychotropic drugs Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved > 3 months) Females who are breastfeeding or pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lopinavir/ritonavir 800 mg / 200mg<br>Kaletra 200/50 mg comprimidos recubiertos con película Lopinavir/ritonavir 800 mg / 200mg will be changed 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 | Drug: Lopinavir/ritonavir 800 mg / 200mg<br>* 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<br>* Other names: Kaletra 200/50 mg comprimidos recubiertos con película;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma viral load <40 copies/mL | HIV Plasma Viral Load <40 copies/ml at week 48. | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | Weeks 4, 8, 12, 16, 24, 36 and 48 | 
| Satisfaction | Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ) | 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) | At least 4 weeks on study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, MONOTHERAPY, PILOT, LOPINAVIR/RITONAVIR