Clinical trial NCT01166477: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Lead sponsor: Sociedad Andaluza de Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2010-07-21
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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).
timeFrame: 24 weeks per patients
Secondary outcomes:
measure: Virologic efficacy assessment for HIV patients on monotherapy based on LPV/r tablet vs triple therapy which would include any protease inhibitor
timeFrame: 24 weeks per patient
measure: 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
timeFrame: 24 weeks per patients
measure: Patient satisfaction assessment for HIV patients that start monotherapy with LPV/r tablets vs triple therapy which would include any protease inhibitor
timeFrame: 24 weeks per patient
measure: Treatment adherence assessment for HIV patients who start on LPV/r monotherapy tablets vs triple therapy which include any protease inhibitor
timeFrame: 24 weeks per patient
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: San Juan
country: Spain
facility: Hospital de San Juan
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital de Torrevieja
state: Alicante
city: Villajoyosa
country: Spain
facility: Hospital de Villajoyosa
state: Alicante
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital General de l'Hospitalet
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Santiago de Compostela
state: La Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr. Negrín
state: Las Palmas
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Tortosa
country: Spain
facility: Hospital Virgen de la Cinta
state: Tarragona
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Basurto
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Almería
country: Spain
facility: Hospital de Torrecárdenas
city: Burgos
country: Spain
facility: Hospital General Yagüe
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Cádiz
country: Spain
facility: Hospital Puerto Real
city: Granada
country: Spain
facility: Hospital Clínico San Cecilio
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: La Coruña
country: Spain
facility: Pilar Vázquez Rodríguez
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Málaga
country: Spain
facility: Hospital Clínico de Málaga
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Sociedad Andaluza de Enfermedades Infecciosas
name: Juan Pasquau, MD
role: PRINCIPAL_INVESTIGATOR
References: