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
- Conditions
- HIV Infection
- Interventions
- Drug: Triple therapy with ritonavir
- Registration Number
- NCT01166477
- Lead Sponsor
- Sociedad Andaluza de Enfermedades Infecciosas
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 228
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triple therapy Triple therapy with ritonavir The patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir Monotherapy Lopinavir and ritonavir Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (31)
Hospital Dr. Negrín
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Virgen de la Cinta
🇪🇸Tortosa, Tarragona, Spain
Hospital de San Juan
🇪🇸San Juan, Alicante, Spain
Hospital de Torrevieja
🇪🇸Torrevieja, Alicante, Spain
Hospital de Villajoyosa
🇪🇸Villajoyosa, Alicante, Spain
Hospital Universitario de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital General de l'Hospitalet
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clínico Santiago de Compostela
🇪🇸Santiago de Compostela, La Coruña, Spain
Hospital de Cruces
🇪🇸Barakaldo, Vizcaya, Spain
Hospital de Basurto
🇪🇸Basurto, Vizcaya, Spain
Hospital General Yagüe
🇪🇸Burgos, Spain
Hospital de Torrecárdenas
🇪🇸Almería, 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 Clínico San Carlos
🇪🇸Madrid, Spain
Pilar Vázquez Rodríguez
🇪🇸La Coruña, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Carlos Haya
🇪🇸Málaga, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Spain
Hospital de Valme
🇪🇸Sevilla, Spain
Hospital Clínico de Málaga
🇪🇸Málaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain