NCT00335686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
Last Updated

February 29, 2008

Status Verified

June 1, 2007

Enrollment Period

2.4 years

First QC Date

June 8, 2006

Last Update Submit

February 19, 2008

Conditions

HIV Infections

Keywords

Mitochondrial toxicityLopinavir-rtvNevirapineDNA mitochondrial/DNA nuclear

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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.

  • and CV<50 copies/mL over at last 6 months

    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

  • 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 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

  • +2 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

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

Drug: 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

Interventions

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

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

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

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

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Hospital C. Universitario de Santiago

Santiago, A Coruña, 15706, Spain

Location

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Can Mises

Ibiza Town, Balearic Islands, 07800, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital de Mataró

Barcelona, Barcelona, 08304, Spain

Location

Hospital de Granollers

Granollers, Barcelona, 08400, Spain

Location

Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital General de Castellón

Castelló, Castellón, 12004, Spain

Location

Hospital de Figueres

Figueres, Girona, 17600, Spain

Location

Hospital de Palamós

Palamós, Girona, 17230, Spain

Location

Hospital C. San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Virgen del Toro

Maó, Menorca, 07701, Spain

Location

Hospital Nuestra Señora del Rosell

Cartagena, Murcia, 30071, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29600, Spain

Location

Hospital C. Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

Hospital Central de Asturias

Asturias, Oviedo, 33006, Spain

Location

Hospital Sant Joan de Reus

Reus, Tarragona, 43201, Spain

Location

Hospital Universitario Joan XXIII de Tarragona

Tarragona, Tarragona, 43007, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

Hospital Xeral Cies de Vigo

Vigo, Vigo, 36204, Spain

Location

Related Publications (1)

  • 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.

    PMID: 19663689DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

lopinavir-ritonavir drug combinationNevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bonaventura Clotet, MD,PhD

    Lluita contra la Sida Foundation-HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 12, 2006

Study Start

October 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

February 29, 2008

Record last verified: 2007-06

Locations

ES(24)