Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients
NCT ID: NCT00335686
Last Updated: 2008-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
67 participants
INTERVENTIONAL
2003-10-31
2006-03-31
Brief Summary
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Detailed Description
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The primary outcome measure of the design of an "NTRI-sparing" bitherapy is to retard the onset of mitochondrial toxicity or reverse it, mainly with regard to the loss of subcutaneous fat or lipoatrophy.
Lopinavir/ritonavir and nevirapine are two antiretrovirals with different mutation patterns and with high antiviral potency. Their combination therefore guarantees antiviral success. The NEKA study endorses efficacy immunologically and virologically (Negredo E. et al, NRTI-sparing regimen. XIV International AIDS Conference. Barcelona 2002. LB PeB9021).
Similarly, the protective effect of nevirapine on lipid metabolism would counteract the negative impact attributed to lopinavir/ritonavir, reducing cardiovascular risk in these patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
2
Nevirapine (Viramune): 1 comp (200mg)/12h
Nevirapine (Viramune): 1 comp (200mg)/12h
Nevirapine (Viramune): 1 comp (200mg)/12h
Interventions
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Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Nevirapine (Viramune): 1 comp (200mg)/12h
Nevirapine (Viramune): 1 comp (200mg)/12h
Eligibility Criteria
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Inclusion Criteria
2. HIV-1 infected patients.
3. Patients on HAART therapy with PIs or NNRTIs.
4. Patients with an undetectable viral load (\<50/80 copies/mL) over the last 6 months (at least 2 determinations separated by 2 months).
5. Hepatic tests \< 5 times the normal value.
6. Subject able to follow the treatment period.
7. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
8. Signature of the informed consent
Exclusion Criteria
2. Suspicion of resistance or documented resistance to any of the investigational drugs.
3. Suspicion of possible bad adherence.
4. Pregnancy or breastfeeding; refusal to follow reliable contraception over the treatment period.
5. Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
6. Patients participating in another clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
OTHER
Germans Trias i Pujol Hospital
OTHER
Responsible Party
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LLuita Sida Foundation
Principal Investigators
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Bonaventura Clotet, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Lluita contra la Sida Foundation-HIV Unit
Locations
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Hospital C. Universitario de Santiago
Santiago, A Coruña, Spain
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Can Mises
Ibiza Town, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Sant Pau
Barcelona, Barcelona, Spain
Hospital de Mataró
Barcelona, Barcelona, Spain
Hospital de Granollers
Granollers, Barcelona, Spain
Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital General de Castellón
Castelló, Castellón, Spain
Hospital de Figueres
Figueres, Girona, Spain
Hospital de Palamós
Palamós, Girona, Spain
Hospital C. San Carlos
Madrid, Madrid, Spain
Hospital Virgen del Toro
Mahon, Menorca, Spain
Hospital Nuestra Señora del Rosell
Cartagena, Murcia, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital C. Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Central de Asturias
Asturias, Oviedo, Spain
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Universitario Joan XXIII de Tarragona
Tarragona, Tarragona, Spain
Hospital Clínico de Valencia
Valencia, Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, Spain
Hospital Xeral Cies de Vigo
Vigo, Vigo, Spain
Countries
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References
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Negredo E, Miro O, Rodriguez-Santiago B, Garrabou G, Estany C, Masabeu A, Force L, Barrufet P, Cucurull J, Domingo P, Alonso-Villaverde C, Bonjoch A, Moren C, Perez-Alvarez N, Clotet B; MULTINEKA Study Group. Improvement of mitochondrial toxicity in patients receiving a nucleoside reverse-transcriptase inhibitor-sparing strategy: results from the Multicenter Study with Nevirapine and Kaletra (MULTINEKA). Clin Infect Dis. 2009 Sep 15;49(6):892-900. doi: 10.1086/605440.
Other Identifiers
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MULTINEKA
Identifier Type: -
Identifier Source: org_study_id