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
Recruitment status was Active, not recruiting
Sponsor:
The Huesped Foundation
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 June 18, 2013