- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159224
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1202ABB
- Fundación Huésped
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Buenos Aires,, Argentina, 1141
- Helios Salud
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British Columbia
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Vancouver, British Columbia, Canada
- University of British Columbia
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Mexico DF, Mexico
- Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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Simplification
Other Names:
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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
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Simplification
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks
Time Frame: 48 weeks
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48 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Pedro E Cahn, MD, PhD, Fundacion Huesped, Buenos Aires, Argentina
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Lopinavir
Other Study ID Numbers
- ACA-ARGE-04-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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