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)
This study has been completed.
Sponsor:
Sociedad Andaluza de Enfermedades Infecciosas
Information provided by (Responsible Party):
Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT01166477
First received: July 19, 2010
Last updated: March 19, 2013
Last verified: October 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Lopinavir and ritonavir Drug: Triple therapy with ritonavir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Sociedad Andaluza de Enfermedades Infecciosas:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 228 |
| Study Start Date: | January 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166477
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 Virgen de las Nieves | |
| Granada, Spain, 18014 | |
| Hospital Clínico San Cecilio | |
| Granada, Spain, 18012 | |
| Pilar Vázquez Rodríguez | |
| La Coruña, Spain, 15006 | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Universitario de La Princesa | |
| Madrid, Spain, 28006 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Gregorio Marañón | |
| Madrid, Spain, 28007 | |
| Hospital Clínico de Málaga | |
| Málaga, Spain, 29010 | |
| Hospital Carlos Haya | |
| 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 Arnau de Vilanova | |
| Valencia, Spain, 46015 | |
| Hospital Clínico de Valencia | |
| Valencia, Spain, 46010 | |
| 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
No publications provided
| Responsible Party: | Sociedad Andaluza de Enfermedades Infecciosas |
| ClinicalTrials.gov Identifier: | NCT01166477 History of Changes |
| Other Study ID Numbers: | SAI-CDV-2009-01 |
| Study First Received: | July 19, 2010 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Protease Inhibitors |
Ritonavir Lopinavir Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013