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)
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| ClinicalTrials.gov Identifier: NCT01166477 |
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Recruitment Status :
Completed
First Posted : July 21, 2010
Last Update Posted : March 20, 2013
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Sponsor:
Sociedad Andaluza de Enfermedades Infecciosas
Information provided by (Responsible Party):
Sociedad Andaluza de Enfermedades Infecciosas
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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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Triple therapy with ritonavir
The patients will continue to take their usual triple therapy, as established in the summary of product characteristics |
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Experimental: Monotherapy
Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid
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Drug: Lopinavir and ritonavir
The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid |
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 ]
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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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 |
| 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 Key Record Dates |
| Last Update Posted: | March 20, 2013 |
| Last Verified: | October 2009 |
Additional relevant MeSH terms:
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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 |