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

HIV Infection Clinical Trial

— QoLKAMON  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166477
• Other study ID #: SAI-CDV-2009-01
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2010
• Last updated: March 19, 2013
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2009
• Source: Sociedad Andaluza de Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• Lopinavir and ritonavir
The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid
• Triple therapy with ritonavir
The patients will continue to take their usual triple therapy, as established in the summary of product characteristics

Locations

Country	Name	City	State
Spain	Hospital de Torrecárdenas	Almería
Spain	Hospital de Cruces	Barakaldo	Vizcaya
Spain	Hospital de Basurto	Basurto	Vizcaya
Spain	Hospital General Yagüe	Burgos
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital Puerto Real	Cádiz
Spain	Hospital Clínico San Cecilio	Granada
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital General de l'Hospitalet	L'Hospitalet de Llobregat	Barcelona
Spain	Pilar Vázquez Rodríguez	La Coruña
Spain	Hospital Dr. Negrín	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital Clínico de Málaga	Málaga
Spain	Hospital de San Juan	San Juan	Alicante
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Santiago de Compostela	Santiago de Compostela	La Coruña
Spain	Hospital de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital de Torrevieja	Torrevieja	Alicante
Spain	Hospital Virgen de la Cinta	Tortosa	Tarragona
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital de Villajoyosa	Villajoyosa	Alicante
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Andaluza de Enfermedades Infecciosas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes