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 (QoLKAMON)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
HIV Infection	Drug: Lopinavir and ritonavir; Drug: Triple therapy with ritonavir	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	228 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	January 2010
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 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	Drug: Triple therapy with ritonavir; The patients will continue to take their usual triple therapy, as established in the summary of product characteristics
Experimental: Monotherapy; Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid	Drug: Lopinavir and ritonavir; The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid

Outcome Measures

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Primary Outcome Measures :

1. 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). [ Time Frame: 24 weeks per patients ]

Secondary Outcome Measures :

1. Virologic efficacy assessment for HIV patients on monotherapy based on LPV/r tablet vs triple therapy which would include any protease inhibitor [ Time Frame: 24 weeks per patient ]
2. 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 [ Time Frame: 24 weeks per patients ]
3. Patient satisfaction assessment for HIV patients that start monotherapy with LPV/r tablets vs triple therapy which would include any protease inhibitor [ Time Frame: 24 weeks per patient ]
4. Treatment adherence assessment for HIV patients who start on LPV/r monotherapy tablets vs triple therapy which include any protease inhibitor [ Time Frame: 24 weeks per patient ]
5. 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 [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Spain
Hospital de San Juan
San Juan, Alicante, Spain, 03550
Hospital de Torrevieja
Torrevieja, Alicante, Spain, 03186
Hospital de Villajoyosa
Villajoyosa, Alicante, Spain, 03570
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital General de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08906
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Clínico Santiago de Compostela
Santiago de Compostela, La Coruña, Spain, 15706
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911
Hospital Virgen de la Cinta
Tortosa, Tarragona, Spain, 43500
Hospital de Cruces
Barakaldo, Vizcaya, Spain, 48904
Hospital de Basurto
Basurto, Vizcaya, Spain, 48013
Hospital de Torrecárdenas
Almería, Spain, 04009
Hospital General Yagüe
Burgos, Spain, 09005
Hospital Puerta del Mar
Cádiz, Spain, 11009
Hospital Puerto Real
Cádiz, Spain, 11510
Hospital Clínico San Cecilio
Granada, Spain, 18012
Hospital Virgen de las Nieves
Granada, Spain, 18014
Pilar Vázquez Rodríguez
La Coruña, Spain, 15006
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Carlos Haya
Málaga, Spain, 29010
Hospital Clínico de Málaga
Málaga, Spain, 29010
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, 38320
Hospital de Valme
Sevilla, Spain, 41014
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41071
Hospital Clínico de Valencia
Valencia, Spain, 46010
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50009

Sponsors and Collaborators

Sociedad Andaluza de Enfermedades Infecciosas

Investigators

Principal Investigator:	Juan Pasquau, MD	Sociedad Andaluza de Enfermedades Infecciosas

More Information

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Responsible Party:	Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:	NCT01166477 History of Changes
Other Study ID Numbers:	SAI-CDV-2009-01
First Posted:	July 21, 2010
Last Update Posted:	March 20, 2013
Last Verified:	October 2009

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Ritonavir; Lopinavir	HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors