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
1 other identifier
interventional
228
1 country
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2010
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 20, 2013
October 1, 2009
1.9 years
July 19, 2010
March 19, 2013
Conditions
Outcome Measures
Primary Outcomes (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).
24 weeks per patients
Secondary Outcomes (5)
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
Study Arms (2)
Triple therapy
ACTIVE COMPARATORThe patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir
Monotherapy
EXPERIMENTALThose patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid
Interventions
The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid
The patients will continue to take their usual triple therapy, as established in the summary of product characteristics
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Hospital de San Juan
San Juan, Alicante, 03550, Spain
Hospital de Torrevieja
Torrevieja, Alicante, 03186, Spain
Hospital de Villajoyosa
Villajoyosa, Alicante, 03570, Spain
Hospital de Torrecárdenas
Almería, Almería, 04009, Spain
Hospital General de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital General Yagüe
Burgos, Burgos, 09005, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, 11009, Spain
Hospital Puerto Real
Cadiz, Cádiz, 11510, Spain
Hospital Clínico San Cecilio
Granada, Granada, 18012, Spain
Hospital Virgen de las Nieves
Granada, Granada, 18014, Spain
Pilar Vázquez Rodríguez
A Coruña, La Coruña, 15006, Spain
Hospital Clínico Santiago de Compostela
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
Hospital Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Carlos Haya
Málaga, Málaga, 29010, Spain
Hospital Clínico de Málaga
Málaga, Málaga, 29010, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain
Hospital de Valme
Seville, Sevilla, 41014, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41071, Spain
Hospital Virgen de la Cinta
Tortosa, Tarragona, 43500, Spain
Hospital Clínico de Valencia
Valencia, Valencia, 46010, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, 46015, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48904, Spain
Hospital de Basurto
Basurto, Vizcaya, 48013, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Pasquau, MD
Sociedad Andaluza de Enfermedades Infecciosas
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 21, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 20, 2013
Record last verified: 2009-10