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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

September 7, 2005
March 12, 2009
April 2005
December 2008   (final data collection date for primary outcome measure)
Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00159224 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Lopinavir/ritonavir simplification strategy
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
March 2009
December 2008   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Mexico
 
NCT00159224
ACA-ARGE-04-001
No
Pedro Cahn, Scientific Director, Fundacion Huesped
The Huesped Foundation
Abbott
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
March 2009

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