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)

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

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 Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Triple therapy with ritonavir; Drug: Lopinavir and ritonavir

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 Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (Estimate): July 21, 2010

Study Record Updates

• Last Update Posted (Estimate): March 20, 2013
• Last Update Submitted That Met QC Criteria: March 19, 2013
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir
• Other Study ID Numbers: SAI-CDV-2009-01