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Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients

Phase 4
Completed
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
Inclusion Criteria
  1. Age >= 18 years.
  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
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Exclusion Criteria
  1. Presence of opportunistic infections and/or recent tumours (< 6 months).
  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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 monthsAt 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 pointAt 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 thereofAt 24 and 48 weeks
and CV<50 copies/mL over at last 6 monthsAt 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 NVPAt 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

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Malaga, M谩laga, Spain

Hospital Nuestra Se帽ora del Rosell

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Cartagena, Murcia, Spain

Hospital Virgen del Toro

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Mah贸n, Menorca, Spain

Hospital Sant Joan de Reus

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Reus, Tarragona, Spain

Hospital Marqu茅s de Valdecilla

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Santander, Spain

Hospital General Universitario de Alicante

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Alicante, Spain

Hospital C. San Carlos

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Madrid, Spain

Hospital Universitario Joan XXIII de Tarragona

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Tarragona, Spain

Hospital de Matar贸

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Barcelona, Spain

Hospital Costa del Sol

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Marbella, M谩laga, Spain

Hospital Central de Asturias

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Asturias, Oviedo, Spain

Hospital de Sant Pau

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Barcelona, Spain

Hospital C. Universitario de Santiago

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Santiago, A Coru帽a, Spain

Hospital Can Mises

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Ibiza, Baleares, Spain

Hospital General Universitario de Elche

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Elche, Alicante, Spain

Hospital Universitari Germans Trias i Pujol

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Badalona, Barcelona, Spain

Hospital de Granollers

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Granollers, Barcelona, Spain

Mutua de Terrassa

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Terrassa, Barcelona, Spain

Hospital de Figueres

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Figueres, Girona, Spain

Hospital General de Castell贸n

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Castello, Castell贸n, Spain

Hospital de Palam贸s

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Palam贸s, Girona, Spain

Hospital Xeral Cies de Vigo

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Vigo, Spain

Hospital Cl铆nico de Valencia

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Valencia, Spain

Hospital Arnau de Vilanova

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Valencia, Spain

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