Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Germans Trias i Pujol Hospital FUNDACIÓ LLUITA CONTRA LA SIDA |
---|---|
Information provided by: | Germans Trias i Pujol Hospital |
ClinicalTrials.gov Identifier: | NCT00335686 |
The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h Drug: Nevirapine (Viramune): 1 comp (200mg)/12h |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised, Prospective Multicentre Clinical Study on the Effect of the Combination of Lopinavir/Rtv + Nevirapine as Maintenance Bitherapy (Without Nucleoside Analogues) in Comparison With a Triple Therapy Including Lopinavir/Rtv + Nucleoside Analogues in HIV-Infected Patients |
Enrollment: | 67 |
Study Start Date: | October 2003 |
Study Completion Date: | March 2006 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: No Intervention
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
|
Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
|
2: No Intervention
Nevirapine (Viramune): 1 comp (200mg)/12h
|
Drug: Nevirapine (Viramune): 1 comp (200mg)/12h
Nevirapine (Viramune): 1 comp (200mg)/12h
|
At the moment it is known that mitochondrial toxicity is the main pathogenic mechanism of toxicity associated with nucleoside analogues, including lipoatrophy, which at facial level is a stigmatising factor for patients with HIV infection.
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital General Universitario de Alicante | |
Alicante, Spain, 03010 | |
Hospital de Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital de Mataró | |
Barcelona, Spain, 08304 | |
Hospital Universitario Joan XXIII de Tarragona | |
Tarragona, Spain, 43007 | |
Hospital Marqués de Valdecilla | |
Santander, Spain, 39008 | |
Hospital C. San Carlos | |
Madrid, Spain, 28040 | |
Hospital Clínico de Valencia | |
Valencia, Spain, 46010 | |
Hospital Arnau de Vilanova | |
Valencia, Spain, 46015 | |
Hospital Xeral Cies de Vigo | |
Vigo, Spain, 36204 | |
Spain, A Coruña | |
Hospital C. Universitario de Santiago | |
Santiago, A Coruña, Spain, 15706 | |
Spain, Alicante | |
Hospital General Universitario de Elche | |
Elche, Alicante, Spain, 03203 | |
Spain, Baleares | |
Hospital Can Mises | |
Ibiza, Baleares, Spain, 07800 | |
Spain, Barcelona | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Hospital de Granollers | |
Granollers, Barcelona, Spain, 08400 | |
Mutua de Terrassa | |
Terrassa, Barcelona, Spain, 08221 | |
Spain, Castellón | |
Hospital General de Castellón | |
Castello, Castellón, Spain, 12004 | |
Spain, Girona | |
Hospital de Palamós | |
Palamós, Girona, Spain, 17230 | |
Hospital de Figueres | |
Figueres, Girona, Spain, 17600 | |
Spain, Málaga | |
Hospital Costa del Sol | |
Marbella, Málaga, Spain, 29600 | |
Hospital C. Universitario Virgen de la Victoria | |
Malaga, Málaga, Spain, 29010 | |
Spain, Menorca | |
Hospital Virgen del Toro | |
Mahón, Menorca, Spain, 07701 | |
Spain, Murcia | |
Hospital Nuestra Señora del Rosell | |
Cartagena, Murcia, Spain, 30071 | |
Spain, Oviedo | |
Hospital Central de Asturias | |
Asturias, Oviedo, Spain, 33006 | |
Spain, Tarragona | |
Hospital Sant Joan de Reus | |
Reus, Tarragona, Spain, 43201 |
Principal Investigator: | Bonaventura Clotet, MD,PhD | Lluita contra la Sida Foundation-HIV Unit |
Responsible Party: | LLuita Sida Foundation ( LLuita Sida Foundation ) |
Study ID Numbers: | MULTINEKA |
Study First Received: | June 8, 2006 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00335686 |
Health Authority: | Spain: Ministry of Health |
Mitochondrial toxicity Lopinavir-rtv Nevirapine DNA mitochondrial/DNA nuclear |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral Lopinavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |