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

This study has been completed.
Information provided by (Responsible Party):
Pedro Cahn, The Huesped Foundation Identifier:
First received: September 7, 2005
Last updated: September 4, 2015
Last verified: September 2015

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.

Condition Intervention Phase
HIV Infections
Drug: Lopinavir/ritonavir simplification strategy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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".

Resource links provided by NLM:

Further study details as provided by The Huesped Foundation:

Primary Outcome Measures:
  • Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Lopinavir/ritonavir simplification strategy
Other Name: Kaletra monotherapy 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
Drug: Lopinavir/ritonavir simplification strategy
Other Name: Kaletra monotherapy simplification strategy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00159224

Fundacion Huesped
Buenos Aires, Argentina, C1202ABB
Helios Salud
Buenos Aires,, Argentina, 1141
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán
Mexico DF, Mexico
Sponsors and Collaborators
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
  More Information

No publications provided by The Huesped Foundation

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pedro Cahn, Scientic Director, The Huesped Foundation, The Huesped Foundation Identifier: NCT00159224     History of Changes
Other Study ID Numbers: ACA-ARGE-04-001
Study First Received: September 7, 2005
Last Updated: September 4, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by The Huesped Foundation:
Treatment Naive
HIV-1 infection

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses processed this record on December 01, 2015