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AzTrials

HIV InfectionsPhase 4NCT00335686

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

A Phase 4 study testing Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h and Nevirapine (Viramune): 1 comp (200mg)/12h in people with HIV Infections, run by Germans Trias i Pujol Hospital at 24 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
HIV Infections
What is being tested?
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h and Nevirapine (Viramune): 1 comp (200mg)/12h
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
24 sitesSpain
Study dates
Oct 2003to Mar 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Spain24 sites

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

  • Hospital Central de Asturias

    Asturias, Oviedo, 33006

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital de Mataró

    Barcelona, Barcelona, 08304

  • Hospital Nuestra Señora del Rosell

    Cartagena, Murcia, 30071

  • Hospital General de Castellón

    Castelló, Castellón, 12004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital de Figueres

    Figueres, Girona, 17600

  • Hospital de Granollers

    Granollers, Barcelona, 08400

  • Hospital Can Mises

    Ibiza Town, Balearic Islands, 07800

  • Hospital C. San Carlos

    Madrid, Madrid, 28040

  • Hospital Virgen del Toro

    Mahón, Menorca, 07701

  • Hospital C. Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Costa del Sol

    Marbella, Málaga, 29600

  • Hospital de Palamós

    Palamós, Girona, 17230

  • Hospital Sant Joan de Reus

    Reus, Tarragona, 43201

  • Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital C. Universitario de Santiago

    Santiago, A Coruña, 15706

  • Hospital Universitario Joan XXIII de Tarragona

    Tarragona, Tarragona, 43007

  • Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010

  • Hospital Arnau de Vilanova

    Valencia, Valencia, 46015

  • Hospital Xeral Cies de Vigo

    Vigo, Vigo, 36204

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h, Nevirapine (Viramune): 1 comp (200mg)/12h
Keywords
Mitochondrial toxicity, Lopinavir-rtv, Nevirapine, DNA mitochondrial/DNA nuclear
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Nevirapine (Viramune): 1 comp (200mg)/12hDrug

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

Study groups in NCT00335686
Study groupRoleWhat they receive
1No interventionLopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Receives: Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
2No interventionNevirapine (Viramune): 1 comp (200mg)/12h
Receives: Drug: Nevirapine (Viramune): 1 comp (200mg)/12h

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At 24 and 48 weeks with regard to the baseline visit

Secondary outcomes (7)

  1. 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

    Measured: At 12, 24, 36 and 48 weeks.

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

    Measured: At 12, 24, 36 and 48 weeks

  3. To determine whether the combination with Lopinavir/rtv +Nevirapine is efficacious in avoiding progression to lipoatrophy/lipodystrophy or else the reversal thereof

    Measured: At 24 and 48 weeks

  4. 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

    Measured: At 12, 24, 36 and 48 weeks.

  5. 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

    Measured: At 12, 24, 36 and 48 weeks

  6. To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine .

    Measured: over 48 weeks of treatment

  7. To evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire).

    Measured: At 12, 24, 36 and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2006 (estimated)
  2. Study startOct 2003
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335686
Sponsor's protocol ID
MULTINEKA
Status last verified
Jun 2007
First submitted
8 Jun 2006
Last updated
29 Feb 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19663689

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h and Nevirapine (Viramune): 1 comp (200mg)/12h in people with HIV Infections, run by Germans Trias i Pujol Hospital at 24 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00335686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2008.

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