Induction-maintenance of Lopinavir/r in HIV-infected Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159224
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 7, 2015
Information provided by (Responsible Party):
Pedro Cahn, The Huesped Foundation

September 7, 2005
September 12, 2005
September 7, 2015
April 2005
December 2009   (Final data collection date for primary outcome measure)
Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks [ Time Frame: 48 weeks ]
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Complete list of historical versions of study NCT00159224 on Archive Site
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Induction-maintenance of Lopinavir/r in HIV-infected Subjects
Study ACA-ARGE-04-001 "A Pilot, Open-Label Study Assessing Safety, Tolerability, Efficacy of a Simplified Lopinavir/Ritonavir Induction/Maintenance Therapy in HIV-Infected Subjects on Their First Protease Inhibitor-Based Regimen".

This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.

The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1.

Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Lopinavir/ritonavir simplification strategy
Other Name: Kaletra monotherapy simplification strategy
  • Experimental: Lopinavir/ritonavir monotherapy
    Patients with undetectable viral load while on 1st line ARV therapy will be randomized to the expermental arm: Lopinavir/ritonavir monotherapy
    Intervention: Drug: Lopinavir/ritonavir simplification strategy
  • Active Comparator: Lopinavir/Ritonavir plus 2 NRTIs
    Patients randomized to this arm will continue with standard of care triple therapy, based on Lopinavir/Ritonavir plus 2 NRTIs
    Intervention: Drug: Lopinavir/ritonavir simplification strategy
Cahn P, Montaner J, Junod P, Patterson P, Krolewiecki A, Andrade-Villanueva J, Cassetti I, Sierra-Madero J, Casiró AD, Bortolozzi R, Lupo SH, Longo N, Rampakakis E, Ackad N, Sampalis JS. Pilot, randomized study assessing safety, tolerability and efficacy of simplified LPV/r maintenance therapy in HIV patients on the 1 PI-based regimen. PLoS One. 2011;6(8):e23726. doi: 10.1371/journal.pone.0023726. Epub 2011 Aug 19.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the trial that are relevant to his or her decision to take part, by signing and dating the IRB / IEC approved informed consent form.
  • Subject is HIV positive and on their first antiretroviral treatment regimen, based on any two NRTIs plus lopinavir/ritonavir or a ritonavir-boosted PI combination. Subject must have had no previous exposure to other regimens.
  • Subject has a viral load <50 copies/ml at the time of baseline evaluation for at least 6 months.
  • Subject has a CD4 cell count ³ 100 cells/mm3.
  • Subject is aged >18 years.
  • Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
  • Subject has not been treated for an active opportunistic infection within 30 days of screening.
  • If female, subject has a negative pregnancy test and agrees to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
  • Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with any of the antiretroviral drugs in their treatment regimen. The subject agrees not to take any medication, including over-the-counter medicine, alcohol, or recreational drugs without the knowledge and permission of the principal investigator

Exclusion Criteria:

  • Subject has current uncontrolled substance abuse or psychiatric illness that could preclude compliance with the protocol.
  • Subject has a viral load of > 50 copies/ml
  • Subject is HBsAg +
  • Subject has active tuberculosis or an opportunistic infection.
  • Subject has active malignancy (except Kaposi's Sarcoma).
  • Subject has liver failure as evidenced by ALT / AST > 5 x Upper Limit of Normal (ULN).
  • Female subject is pregnant or lactating.
  • Subject has received an investigational drug within 30 days prior to the initiation of the study.
  • Subject has modified his/her antiretroviral therapy during the 3 months prior to baseline or is intending to do so during the course of the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Mexico
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Pedro Cahn, The Huesped Foundation
The Huesped Foundation
Study Chair: Pedro E Cahn, MD, PhD Fundacion Huesped, Buenos Aires, Argentina
Principal Investigator: Julio SG Montaner, MD University of British Columbia
Principal Investigator: Isabel L Cassetti, MD Helios Salud, Buenos Aires, Argentina
Principal Investigator: Juan Sierra Madero, MD Instituto Nacional de Ciencias Medicas y Nutricio Salvador Zurbaran, Mexico
The Huesped Foundation
September 2015

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