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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000625 |
To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 |
Estimated Enrollment: | 2100 |
Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm.
PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
PER AMENDMENT 4/5/95:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Current alcohol abuse.
Study Chair: | Katzenstein D | |
Study Chair: | Hammer S |
Study ID Numbers: | ACTG 175 |
Study First Received: | November 2, 1999 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00000625 |
Health Authority: | United States: Federal Government |
Zalcitabine Didanosine Drug Therapy, Combination |
AIDS-Related Complex Antiviral Agents Zidovudine |
Virus Diseases Sexually Transmitted Diseases, Viral Didanosine HIV Infections Zalcitabine Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |