Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00335686
- Lead Sponsor
- Germans Trias i Pujol Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- Age >= 18 years.
- HIV-1 infected patients.
- Patients on HAART therapy with PIs or NNRTIs.
- Patients with an undetectable viral load (<50/80 copies/mL) over the last 6 months (at least 2 determinations separated by 2 months).
- Hepatic tests < 5 times the normal value.
- Subject able to follow the treatment period.
- 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.
- Signature of the informed consent
- Presence of opportunistic infections and/or recent tumours (< 6 months).
- Suspicion of resistance or documented resistance to any of the investigational drugs.
- Suspicion of possible bad adherence.
- Pregnancy or breastfeeding; refusal to follow reliable contraception over the treatment period.
- Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
- Patients participating in another clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary outcome measures are changes in the mDNA/nDNA ratio at each visit with regard to the baseline visit. At 24 and 48 weeks with regard to the baseline visit
- Secondary Outcome Measures
Name Time Method Study of the efficacy of the therapy with Lopinavir/rtv (3 tablets every 12 h) + Nevirapine (1 tablet every 12 h) in the maintenance of viral suppression and immune recovery in patients on HAART therapy for more than 9 months At 12, 24, 36 and 48 weeks. To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine . over 48 weeks of treatment To check whether the simplified combination with the standard dose of Lopinavir/rtv with NVP is sufficient to maintain suppression of viral replication. Pharmacokinetic studies (PK) would be performed to estimate this point At 12, 24, 36 and 48 weeks To determine whether the combination with Lopinavir/rtv +Nevirapine is efficacious in avoiding progression to lipoatrophy/lipodystrophy or else the reversal thereof At 24 and 48 weeks and CV<50 copies/mL over at last 6 months At 12, 24, 36 and 48 weeks To study whether the combination with Lopinavir/rtv +Nevirapine makes it possible to control dyslipidemia associated with the use of Lopinavir/rtv on proving the "lipid-lowering" action of NVP At 12, 24, 36 and 48 weeks. To evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire). At 12, 24, 36 and 48 weeks
Trial Locations
- Locations (24)
Hospital C. Universitario Virgen de la Victoria
馃嚜馃嚫Malaga, M谩laga, Spain
Hospital Nuestra Se帽ora del Rosell
馃嚜馃嚫Cartagena, Murcia, Spain
Hospital Virgen del Toro
馃嚜馃嚫Mah贸n, Menorca, Spain
Hospital Sant Joan de Reus
馃嚜馃嚫Reus, Tarragona, Spain
Hospital Marqu茅s de Valdecilla
馃嚜馃嚫Santander, Spain
Hospital General Universitario de Alicante
馃嚜馃嚫Alicante, Spain
Hospital C. San Carlos
馃嚜馃嚫Madrid, Spain
Hospital Universitario Joan XXIII de Tarragona
馃嚜馃嚫Tarragona, Spain
Hospital de Matar贸
馃嚜馃嚫Barcelona, Spain
Hospital Costa del Sol
馃嚜馃嚫Marbella, M谩laga, Spain
Hospital Central de Asturias
馃嚜馃嚫Asturias, Oviedo, Spain
Hospital de Sant Pau
馃嚜馃嚫Barcelona, Spain
Hospital C. Universitario de Santiago
馃嚜馃嚫Santiago, A Coru帽a, Spain
Hospital Can Mises
馃嚜馃嚫Ibiza, Baleares, Spain
Hospital General Universitario de Elche
馃嚜馃嚫Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol
馃嚜馃嚫Badalona, Barcelona, Spain
Hospital de Granollers
馃嚜馃嚫Granollers, Barcelona, Spain
Mutua de Terrassa
馃嚜馃嚫Terrassa, Barcelona, Spain
Hospital de Figueres
馃嚜馃嚫Figueres, Girona, Spain
Hospital General de Castell贸n
馃嚜馃嚫Castello, Castell贸n, Spain
Hospital de Palam贸s
馃嚜馃嚫Palam贸s, Girona, Spain
Hospital Xeral Cies de Vigo
馃嚜馃嚫Vigo, Spain
Hospital Cl铆nico de Valencia
馃嚜馃嚫Valencia, Spain
Hospital Arnau de Vilanova
馃嚜馃嚫Valencia, Spain