Clinical Trials

MainTitle

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

This study has been completed
Sponsor
The Huesped Foundation

Collaborator
Abbott

Information provided by (Responsible Party)
Pedro Cahn, The Huesped Foundation

ClinicalTrials.gov Identifier
NCT00159224

First received: September 7, 2005
Last updated: September 4, 2015
Last Verified: September 2015
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: None (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".

Further study details as provided by Pedro Cahn, The Huesped Foundation:

Primary Outcome Measures

  • Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks [ Time Frame: 48 weeks ]

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

Simplification

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

Simplification

Other Name: Kaletra monotherapy simplification strategy
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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
Helios Salud
Buenos Aires,, Argentina, 1141
Fundacion Huesped
Buenos Aires, Argentina, C1202ABB
Canada
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

More Information


Responsible Party: Pedro Cahn, Scientic Director, The Huesped Foundation, The Huesped Foundation  
ClinicalTrials.gov Identifier: NCT00159224   History of Changes  
Other Study ID Numbers: ACA-ARGE-04-001  
Study First Received: September 7, 2005  
Last Updated: September 4, 2015  

Keywords provided by Pedro Cahn, The Huesped Foundation:

HIV
Simplification
Monotherapy
Treatment Naive
HIV-1 infection

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.