Induction-Maintenance of Lopinavir/r in HIV-Infected Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by The Huesped Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
The Huesped Foundation
ClinicalTrials.gov Identifier:
NCT00159224
First received: September 7, 2005
Last updated: March 12, 2009
Last verified: March 2009
  Purpose

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 ]

Estimated Enrollment: 100
Study Start Date: April 2005
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00159224

Locations
Argentina
Fundacion Huesped
Buenos Aires, Argentina, C1202ABB
Helios Salud
Buenos Aires,, Argentina, 1141
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Mexico
Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán
Mexico DF, Mexico
Sponsors and Collaborators
The Huesped Foundation
Abbott
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pedro Cahn, Scientific Director, Fundacion Huesped
ClinicalTrials.gov Identifier: NCT00159224     History of Changes
Other Study ID Numbers: ACA-ARGE-04-001
Study First Received: September 7, 2005
Last Updated: March 12, 2009
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Ritonavir
Lopinavir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014