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Sponsored by: |
Federal University of Rio de Janeiro |
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Information provided by: | Federal University of Rio de Janeiro |
ClinicalTrials.gov Identifier: | NCT00160849 |
Objectives Primary
Secondary
Patient population:
The 60 patients were selected by the investigators according to the study’s inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each.
Study design:
The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded.
Regime:
96 weeks of treatment
Condition | Intervention | Phase |
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HIV Infections |
Drug: Lopinavir/r |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study on the Feasibility of Antiretroviral Therapy With a Single Agent - Lopinavir/r - in Patients Treated With HAART and With Viral Load Below 80 Copies/Ml |
Estimated Enrollment: | 60 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | March 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Projeto Praça Onze | |
Rio de Janeiro, Brazil, 20210.030 | |
Brazil, Rio de Janeiro | |
Hospital Geral de Nova Iguaçu | |
Nova Iguaçu, Rio de Janeiro, Brazil, 01620.020 |
Principal Investigator: | Estevão P Nunes, M.Sc | Projeto Praça Onze |
Study ID Numbers: | KalMo |
Study First Received: | September 8, 2005 |
Last Updated: | October 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00160849 |
Health Authority: | Brazil: National Committee of Ethics in Research |
Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |