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HIV InfectionsPhase 3KALESOLONCT00140751

Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients

A Phase 3 study testing Lopinavir/ritonavir (drug) in people with HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 25 sites in France.

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 purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Lopinavir/ritonavir (drug)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
25 sitesFrance
Study dates
Oct 2005to Jan 2008
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > or = 18 years
  • Confirmed HIV-1 seropositivity
  • Antiretroviral treatment stable since 3 months at least
  • HIV-1 ARN load < 50 copies/mL since 6 months at least
  • Signed consent form
  • No history of treatment failure (= viral load > 1000 copies/mL) including a protease inhibitor
  • No opportunistic infection in the previous 6 months

Who cannot join

  • Neutrophils < 750/mm3
  • Hemoglobin < 8 g/dL
  • Platelets < 60,000/mm3
  • Creatinin > 150 micromoles/L
  • SGOT > 5 NUL (Normal Upper Limit)
  • SGPT > 5 NUL
Show all 10Show fewer
  • Current IL-2 treatment
  • HBV infection treated or not by lamivudine or tenofovir
  • Pregnancy or feeding
  • Enrollment in another study not compliant with KALESOLO Study group assignment

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

France25 sites

  • Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie

    Annecy, 74000

  • Hôpital Jean Verdier - Unité de Maladies Infectieuses

    Bondy, 93143

  • Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

    Bordeaux, 33000

  • Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses

    Bordeaux, 33000

  • Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales

    Bordeaux, 33000

  • Hôpital Côte de Nacre - Service des Maladies Infectieuses

    Caen, 14033

  • Hôpital Henri Mondor - Service d'Immunologie Clinique

    Créteil, 94010

  • Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales

    Fort-de-France, Martinique, 97261

  • Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales

    Garches, 92380

  • Hôpital A. Michallon - Service des Maladies Infectieuses

    Grenoble, 38000

  • Hôpital Bicêtre - Service de Médecine Interne

    Le Kremlin-Bicêtre, 94275

  • Hôpital Nord - CISIH

    Marseille, 13020

  • Hôpital Sainte-Marguerite - Unité Médicale CISIH

    Marseille, 13274

  • Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

    Montpellier, 34000

  • Hôpital de l'Archet - Service d'Infectiologie

    Nice, 06200

  • Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales

    Paris, 75012

  • Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales

    Paris, 75013

  • Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1

    Paris, 75013

  • Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses

    Paris, 75014

  • Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie

    Paris, 75015

  • Hôpital Tenon - Service des Maladies Infectieuses et Tropicales

    Paris, 75020

  • Hôpital Pontchaillou - Service des Maladies Infectieuses

    Rennes, 35000

  • Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A

    Strasbourg, 67000

  • Hôpital Gustave Dron - Service des Maladies Infectieuses

    Tourcoing, 59200

  • Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: A 48-Weeks National Multicenter Randomized Open Clinical Trial Evaluating Tolerance and Efficacy of a Treatment Simplification by Lopinavir/Ritonavir Versus Continuation of Current Treatment in HIV-Infected Patients With a Viral Load Inferior to 50 Copies/mL Since 6 Months At Least

The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients

Read the detailed description

Highly active antiretroviral therapy (HAART) has made a significant impact on the natural history of HIV-1 infection, but toxicities and complexities of therapy limit long-term efficacy, and make simpler yet effective HAART regimens highly desirable. Previous attempts to 'de-intensify' protease inhibitor (PI)-based therapy by discontinuing reverse transcriptase inhibitors (RTI) after achieving viral suppression met with failure, probably because plasma levels of most individually administered PI are too low to inhibit viral replication consistently.

Low-dose ritonavir substantially enhances lopinavir plasma levels, and lopinavir/ritonavir (LPV/r) is effective as part of a combination therapy in both naive and PI-experienced patients. Furthermore, lopinavir is known to have a high genetic barrier to selection of resistance. LPV/r monotherapy could thus have the right combination of potency, favorable pharmacokinetics, and high genetic barrier needed to suppress viral replication and prevent the selection of lopinavir resistance. Preliminary results with "maintenance"LPV/r monotherapy show interesting results but data from randomized studies are needed.

Conditions
HIV Infections
Being tested
Lopinavir/ritonavir (drug)
Keywords
HIV-1, Treatment simplification, Lopinavir/ritonavir, Treatment Experienced, HIV Seropositivity
Medical subject headings
HIV Infections, HIV Seropositivity

What participants receive

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

  • Lopinavir/ritonavir (drug)Drug

Study groups in NCT00140751
Study groupRoleWhat they receive
SimplificationExperimentalThe patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks
Receives: Drug: Lopinavir/ritonavir (drug)
ContinuedNo interventionThe patients included in this arm continue their treatment without any changes

What is being measured

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

  1. Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study

    Measured: W48

Secondary outcomes (8)

  1. Durability of viral response

    Measured: W48

  2. Evolution of lymphocytes CD4

    Measured: W48

  3. Observance

    Measured: W48

  4. Clinical and biological tolerance

    Measured: W48

  5. Quantitative and qualitative changes in quality of life data

    Measured: W48

  6. Cost-efficacy ratio

    Measured: W48

  7. Predictive value of proviral DNA before treatment simplification

    Measured: W48

  8. Proportion of patients showing a lipodystrophy at J0 and S48

    Measured: W48

Timeline

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

  1. First posted1 Sep 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionJan 2008
  4. Study completionJan 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140751
Sponsor's protocol ID
IMEA-030
Other IDs
KALESOLO
Acronym
KALESOLO
Status last verified
Sep 2013
First submitted
30 Aug 2005
Last updated
19 Sep 2013
Results posted
No

Publications

  • Mocroft A, Ledergerber B, Katlama C, Kirk O, Reiss P, d'Arminio Monforte A, Knysz B, Dietrich M, Phillips AN, Lundgren JD; EuroSIDA study group. Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet. 2003 Jul 5;362(9377):22-9. doi: 10.1016/s0140-6736(03)13802-0.

    PubMed 12853195

  • Yeni PG, Hammer SM, Hirsch MS, Saag MS, Schechter M, Carpenter CC, Fischl MA, Gatell JM, Gazzard BG, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Schooley RT, Thompson MA, Vella S, Volberding PA. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA. 2004 Jul 14;292(2):251-65. doi: 10.1001/jama.292.2.251.

    PubMed 15249575

  • Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS. 2001 Jul 27;15(11):1369-77. doi: 10.1097/00002030-200107270-00006.

    PubMed 11504958

  • Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.

    PubMed 9516219

  • Murphy R, Gazzard B. Antiretroviral treatment guidelines. AIDS. 2003 Jun;17 Suppl 2:S1. doi: 10.1097/00002030-200306002-00001. No abstract available.

    PubMed 12870522

  • Bucher HC, Kofler A, Nuesch R, Young J, Battegay M, Opravil M. Meta-analysis of randomized controlled trials of simplified versus continued protease inhibitor-based antiretroviral therapy in HIV-1-infected patients. AIDS. 2003 Nov 21;17(17):2451-9. doi: 10.1097/00002030-200311210-00007.

    PubMed 14600516

  • Drechsler H, Powderly WG. Switching effective antiretroviral therapy: a review. Clin Infect Dis. 2002 Nov 15;35(10):1219-30. doi: 10.1086/343050. Epub 2002 Oct 21.

    PubMed 12410482

  • Martinez E, Conget I, Lozano L, Casamitjana R, Gatell JM. Reversion of metabolic abnormalities after switching from HIV-1 protease inhibitors to nevirapine. AIDS. 1999 May 7;13(7):805-10. doi: 10.1097/00002030-199905070-00009.

    PubMed 10357379

  • Moyle G, Baldwin C, Mandalia S, Comitis S, Burn P, Gazzard B. Changes in metabolic parameters and body shape after replacement of protease inhibitor With efavirenz in virologically controlled HIV-1-positive persons: single-arm observational cohort. J Acquir Immune Defic Syndr. 2001 Dec 1;28(4):399-401. doi: 10.1097/00126334-200112010-00016. No abstract available.

    PubMed 11707680

  • Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.

    PubMed 29767684

  • Meynard JL, Bouteloup V, Landman R, Bonnard P, Baillat V, Cabie A, Kolta S, Izopet J, Taburet AM, Mercie P, Chene G, Girard PM; KALESOLO Study Group. Lopinavir/ritonavir monotherapy versus current treatment continuation for maintenance therapy of HIV-1 infection: the KALESOLO trial. J Antimicrob Chemother. 2010 Nov;65(11):2436-44. doi: 10.1093/jac/dkq327. Epub 2010 Sep 15.

    PubMed 20843990

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lopinavir/ritonavir (drug) in people with HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 25 sites in France.

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 7 inclusion and 10 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 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study (time frame: W48). 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 NCT00140751, which also lists 11 linked publications.

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 19 Sep 2013.

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