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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000978 |
To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or advanced AIDS-related complex (ARC).
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Zidovudine Drug: Zalcitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | An Open-Label, Randomized, Dose-Finding, Multicenter Trial of Dideoxycytidine (ddC) Administered Concurrently With Zidovudine (AZT) in the Treatment of AIDS or Advanced ARC |
Estimated Enrollment: | 68 |
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.
Patients are randomly assigned to one of six treatment groups of various dose combinations of AZT and ddC. Patients are evaluated every week for the first 10 weeks and biweekly thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients are excluded if unwilling or unable to sign informed consent.
Prior Medication:
Excluded:
Positive antibody to HIV using any federally licensed ELISA test kit. Diagnosis of AIDS or AIDS-related complex (ARC).
Active substance or alcohol abuse.
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 |
Study ID Numbers: | ACTG 106, Protocol N3447 |
Study First Received: | November 2, 1999 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00000978 |
Health Authority: | United States: Federal Government |
Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Virus Diseases Signs and Symptoms Sexually Transmitted Diseases, Viral 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 |