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

This study has been completed.
Sponsor:
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00335686
First received: June 8, 2006
Last updated: February 19, 2008
Last verified: June 2007

June 8, 2006
February 19, 2008
October 2003
March 2006   (final data collection date for primary outcome measure)
The primary outcome measures are changes in the mDNA/nDNA ratio at each visit with regard to the baseline visit. [ Time Frame: At 24 and 48 weeks with regard to the baseline visit ] [ Designated as safety issue: No ]
The primary outcome measures are changes in the mDNA/nDNA ratio at each visit with regard to the baseline visit.
Complete list of historical versions of study NCT00335686 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: At 12, 24, 36 and 48 weeks. ] [ Designated as safety issue: No ]
  • and CV<50 copies/mL over at last 6 months [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • To determine whether the combination with Lopinavir/rtv +Nevirapine is efficacious in avoiding progression to lipoatrophy/lipodystrophy or else the reversal thereof [ Time Frame: At 24 and 48 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At 12, 24, 36 and 48 weeks. ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine . [ Time Frame: over 48 weeks of treatment ] [ Designated as safety issue: Yes ]
  • To evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire). [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
  • 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
  • and CV<50 copies/mL over at l
  • To determine whether the combination with Lopinavir/rtv +Nevirapine is efficacious in avoiding progression to lipoatrophy/lipodystrophy or else the reversal thereof
  • To study whether the combination with Lopinavir/rtv +Nevirapine makes it possible to control dyslipemia associated with the use of Lopinavir/rtv on proving the “lipid-lowering” action of NVP
  • 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
  • To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine over 48 weeks of treatment.
  • To evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire).
Not Provided
Not Provided
 
Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
    Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
  • Drug: Nevirapine (Viramune): 1 comp (200mg)/12h
    Nevirapine (Viramune): 1 comp (200mg)/12h
  • No Intervention: 1
    Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
    Intervention: Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
  • No Intervention: 2
    Nevirapine (Viramune): 1 comp (200mg)/12h
    Intervention: Drug: Nevirapine (Viramune): 1 comp (200mg)/12h
Negredo E, Miró O, Rodríguez-Santiago B, Garrabou G, Estany C, Masabeu A, Force L, Barrufet P, Cucurull J, Domingo P, Alonso-Villaverde C, Bonjoch A, Morén C, Pérez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2006
March 2006   (final data collection date for primary outcome measure)

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

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00335686
MULTINEKA
No
LLuita Sida Foundation
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Principal Investigator: Bonaventura Clotet, MD,PhD Lluita contra la Sida Foundation-HIV Unit
Germans Trias i Pujol Hospital
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP