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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006617 |
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues.
HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.
Condition | Intervention |
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HIV Infections |
Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD) |
Estimated Enrollment: | 25 |
With effective combination ART, there is a decrease in HIV-1 RNA in plasma after 2 to 3 weeks. A second, slower phase of viral decay is thought to occur in long-lived macrophages, with a minimal contribution from lymphocytes. This study addresses whether there is a third reservoir such as the central nervous system. Additionally, the study aims to provide a better understanding of the type and length of ART required to suppress HIV-1 replication in multiple reservoirs.
Patients receive treatment with ZDV, 3TC, ABC, and APV daily for 24 weeks. Clinic visits occur weekly until Week 4, then every 2 weeks until Week 12, then monthly. Blood and urine samples are collected and patients are monitored for clinical or laboratory abnormalities. Laboratory tests to assess side effects and virologic and immunologic parameters, including viral quantification of CSF on all chronically infected patients and selected consenting acutely infected patients, are determined. In a pharmacoeconomic component of this study, patients have interviews and complete questionnaires at 5 clinic visits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Study ID Numbers: | AIEDRP AI-04-008, PROA2003 |
Study First Received: | December 6, 2000 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00006617 |
Health Authority: | United States: Federal Government |
HIV-1 Drug Therapy, Combination Zidovudine Lymphoid Tissue Gastrointestinal System HIV Protease Inhibitors Lamivudine |
Lymphocyte Subsets VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Cerebrospinal Fluid abacavir |
Virus Diseases Amprenavir Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Lamivudine Zidovudine Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Protease Inhibitors Antibiotics, Antitubercular Reverse Transcriptase Inhibitors Anti-Bacterial Agents Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents Nucleic Acid Synthesis Inhibitors |