Clinical Trial, Open-label, Randomised, in Order to Compare the Quality of Life for Those VIH+ Patients That Start With Monotherapy on LPV/r Tablets Vs. Triple Therapy With a Boosted Protease Inhibitor

Study Overview
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Brief Summary
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The Study will help to compare the Quality of Life for those HIV patients that are on monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor

Detailed Description
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The Study will help to compare the Quality of Life for those HIV patients that are on monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor.

Official Title
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Ensayo clínico, Abierto, Aleatorizado Para Comparar la Calidad de Vida de Los Pacientes VIH+ Que Inician Monoterapia Con Comprimidos de LPV/r vs Triple Terapia Que Contenga un IP Potenciado

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Lopinavir and ritonavir
* Drug: Triple therapy with ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients infected with HIV-1, documented with a positive HIV-1 antibodies test and/or positive PCR confirmed for HIV-1 RNA. Patients on triple antiretroviral therapy with any boosted protease inhibitor. Patients with an undetectable viral load, which will be defined as <50 viral RNA copies/mL within the last six months. Men or women aged≥18. For women with childbearing potential, negative urine pregnancy test during the Screening visit. Patients who would have granted a written informed consent prior to any Study-specific screening procedure. Exclusion Criteria: Patients with a written proof of resistance in the accumulated genotype, which would lead to a sensibility loss to lopinavir/ritonavir, or, in case of genotype absence, a documented failure to a protease inhibitor therapy. Patients with a CD4 cells nadir CD4 <100 cell/microL. Patients who, for any reason, could not be treated with lopinavir/ritonavir. Prior medical history of psychiatric disorders, such as depressive syndrome, schizophrenia or psychotic disease. Known previous medical history of drug abuse/addiction or alcohol chronic consumption, which in the Investigator's opinion, would be incompatible with his/her Study participation. Pregnant or breastfeeding women, or women of childbearing potential who do not use an appropriate contraceptive method, according to the Investigator's opinion. Documented past(within four weeks prior to screening) or active current opportunistic infection. Patients who, due to severe toxicities related to any of their current HAART compounds, there is a planned discontinuation or modification concerning any of the drugs from their triple therapy. Patients for which, according to the Investigator, will have to change their HAART, regardless of the reason, within the next six months. Renal disease with creatinine clearance <60 mL/min. Concomitant use of Lopinavir/ritonavir contraindicated drugs, such as rifampicin, dihydroergotamine, ergotamine, methylergonovine, cisapride, hypericum perforatum, lovastatin, simvastatin, pimozide, midazolam and triazolam. Concomitant use of nephrotoxic or immunosuppressor drugs. Patients currently treated with systemic corticosteroids, interleukine-2 or chemotherapy. Patients treated with other Investigative Medical Product. Patients with acute hepatitis. Any disease or condition that, according to the Investigator, would be incompatible with the patient's participation in the Study.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triple therapy<br>The patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir | Drug: Triple therapy with ritonavir<br>* The patients will continue to take their usual triple therapy, as established in the summary of product characteristics<br>|
| Experimental: Monotherapy<br>Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid | Drug: Lopinavir and ritonavir<br>* The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life comparison for HIV patients that start monotherapy with lopinavir/ritonavir (LPV/r) tablets vs patients with triple therapy which would include any boosted protease inhibitor (PI). |  | 24 weeks per patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic efficacy assessment for HIV patients on monotherapy based on LPV/r tablet vs triple therapy which would include any protease inhibitor |  | 24 weeks per patient | 
| Immune response changes assessment for those HIV patients who start monotherapy with LPV/r tablets vs HIV patients on triple therapy which would include any protease inhibitor |  | 24 weeks per patients | 
| Patient satisfaction assessment for HIV patients that start monotherapy with LPV/r tablets vs triple therapy which would include any protease inhibitor |  | 24 weeks per patient | 
| Treatment adherence assessment for HIV patients who start on LPV/r monotherapy tablets vs triple therapy which include any protease inhibitor |  | 24 weeks per patient | 
| Tolerability and safety assessment for the HIV patients who start monotherapy treatment with LPV/r tablets vs triple therapy which would include any protease inhibitor |  | 24 weeks |