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

NCT ID: NCT01166477

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

Brief Summary

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

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triple therapy

The patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir

Group Type: ACTIVE_COMPARATOR

Triple therapy with ritonavir

Intervention Type: DRUG

The patients will continue to take their usual triple therapy, as established in the summary of product characteristics

Monotherapy

Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid

Group Type: EXPERIMENTAL

Lopinavir and ritonavir

Intervention Type: DRUG

The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid

Interventions

Lopinavir and ritonavir

The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid

Intervention Type: DRUG

Triple therapy with ritonavir

The patients will continue to take their usual triple therapy, as established in the summary of product characteristics

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Andaluza de Enfermedades Infecciosas

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Pasquau, MD

Role: PRINCIPAL_INVESTIGATOR

Sociedad Andaluza de Enfermedades Infecciosas

Locations

Hospital de San Juan

San Juan, Alicante, Spain

Hospital de Torrevieja

Torrevieja, Alicante, Spain

Hospital de Villajoyosa

Villajoyosa, Alicante, Spain

Hospital de Torrecárdenas

Almería, Almería, Spain

Hospital General de l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital General Yagüe

Burgos, Burgos, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Hospital Puerto Real

Cadiz, Cádiz, Spain

Hospital Clínico San Cecilio

Granada, Granada, Spain

Hospital Virgen de las Nieves

Granada, Granada, Spain

Pilar Vázquez Rodríguez

A Coruña, La Coruña, Spain

Hospital Clínico Santiago de Compostela

Santiago de Compostela, La Coruña, Spain

Hospital Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Severo Ochoa

Leganés, Madrid, Spain

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Carlos Haya

Málaga, Málaga, Spain

Hospital Clínico de Málaga

Málaga, Málaga, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Hospital de Valme

Seville, Sevilla, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Hospital Virgen de la Cinta

Tortosa, Tarragona, Spain

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Hospital Arnau de Vilanova

Valencia, Valencia, Spain

Hospital de Cruces

Barakaldo, Vizcaya, Spain

Hospital de Basurto

Basurto, Vizcaya, Spain

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

SAI-CDV-2009-01

Identifier Type: -

Identifier Source: org_study_id