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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Nevirapine (Viramune): 1 comp (200mg)/12h
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Mitochondrial toxicity, Lopinavir-rtv, Nevirapine, DNA mitochondrial/DNA nuclear

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Hospital C. Universitario de Santiago
  • Hospital General Universitario de Elche
  • Hospital Can Mises
  • Hospital Universitari Germans Trias i Pujol
  • Hospital de Granollers
  • Mutua de Terrassa
  • Hospital General de Castellón
  • Hospital de Figueres
  • Hospital de Palamós
  • Hospital Virgen del Toro
  • Hospital Nuestra Señora del Rosell
  • Hospital C. Universitario Virgen de la Victoria
  • Hospital Costa del Sol
  • Hospital Central de Asturias
  • Hospital Sant Joan de Reus
  • Hospital General Universitario de Alicante
  • Hospital de Sant Pau
  • Hospital de Mataró
  • Hospital C. San Carlos
  • Hospital Marqués de Valdecilla
  • Hospital Universitario Joan XXIII de Tarragona
  • Hospital Clínico de Valencia
  • Hospital Arnau de Vilanova
  • Hospital Xeral Cies de Vigo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

No Intervention

Arm Label

1

2

Arm Description

Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h

Nevirapine (Viramune): 1 comp (200mg)/12h

Outcomes

Primary Outcome Measures

The primary outcome measures are changes in the mDNA/nDNA ratio at each visit with regard to the baseline visit.

Secondary Outcome Measures

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 last 6 months
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 dyslipidemia 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 .
To evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire).

Full Information

First Posted
June 8, 2006
Last Updated
February 19, 2008
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
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1. Study Identification

Unique Protocol Identification Number
NCT00335686
Brief Title
Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Mitochondrial toxicity, Lopinavir-rtv, Nevirapine, DNA mitochondrial/DNA nuclear

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Arm Title
2
Arm Type
No Intervention
Arm Description
Nevirapine (Viramune): 1 comp (200mg)/12h
Intervention Type
Drug
Intervention Name(s)
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Intervention Description
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Intervention Type
Drug
Intervention Name(s)
Nevirapine (Viramune): 1 comp (200mg)/12h
Intervention Description
Nevirapine (Viramune): 1 comp (200mg)/12h
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Title
and CV<50 copies/mL over at last 6 months
Time Frame
At 12, 24, 36 and 48 weeks
Title
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
Title
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.
Title
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
Title
To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine .
Time Frame
over 48 weeks of treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonaventura Clotet, MD,PhD
Organizational Affiliation
Lluita contra la Sida Foundation-HIV Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital C. Universitario de Santiago
City
Santiago
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Can Mises
City
Ibiza
State/Province
Baleares
ZIP/Postal Code
07800
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Granollers
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08400
Country
Spain
Facility Name
Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital General de Castellón
City
Castello
State/Province
Castellón
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital de Figueres
City
Figueres
State/Province
Girona
ZIP/Postal Code
17600
Country
Spain
Facility Name
Hospital de Palamós
City
Palamós
State/Province
Girona
ZIP/Postal Code
17230
Country
Spain
Facility Name
Hospital Virgen del Toro
City
Mahón
State/Province
Menorca
ZIP/Postal Code
07701
Country
Spain
Facility Name
Hospital Nuestra Señora del Rosell
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30071
Country
Spain
Facility Name
Hospital C. Universitario Virgen de la Victoria
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29600
Country
Spain
Facility Name
Hospital Central de Asturias
City
Asturias
State/Province
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43201
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital de Mataró
City
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
Hospital C. San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Joan XXIII de Tarragona
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Xeral Cies de Vigo
City
Vigo
ZIP/Postal Code
36204
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19663689
Citation
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.
Results Reference
derived

Learn more about this trial

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

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