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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000731 |
Purpose
To determine if zidovudine (AZT) and acetaminophen (APAP) interact when given to the same patient, and if so, the manner of interaction. Patients with AIDS often require therapy with painkillers for the management of mild pain and discomfort associated with their disease, and APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for doctors to understand how AZT and APAP may interact when given to the same patient, because other studies have suggested that the dosage of AZT may have to be adjusted when given with APAP in order to avoid or minimize adverse effects.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: Acetaminophen |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Pharmacokinetics Study |
| Official Title: | Evaluation of the Interaction Between Acetaminophen and Zidovudine |
| Estimated Enrollment: | 10 |
Patients with AIDS often require therapy with painkillers for the management of mild pain and discomfort associated with their disease, and APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for doctors to understand how AZT and APAP may interact when given to the same patient, because other studies have suggested that the dosage of AZT may have to be adjusted when given with APAP in order to avoid or minimize adverse effects.
Persons who are infected with HIV and have symptoms (fever, fatigue, weight loss) of AIDS are eligible for the study. They will be given AZT orally every 4 hours or APAP orally every 8 hours alone or in combination for 4 days while at home. On the 4th day, participants will be admitted to a clinical research center for studies to determine how they are tolerating the medicine. On the 5th day, any scheduled 8 am doses of AZT will be given intravenously, while the scheduled doses of APAP will still be given orally. Repeated blood samples will be taken over the next 12 hours and urine will be collected for 24 hours. The process will be repeated at weekly intervals for 3 weeks, so that each patient receives AZT alone, APAP alone, and the combination of AZT and APAP.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Patients with the following are excluded:
AIDS related complex (ARC) defined as presence of any one of the following within 12 months prior to entry and absence of a concurrent illness or condition other than
HIV infection to explain the findings:
Inability to abstain from alcohol or any other drug, including nonprescription medications, during the study period.
Contacts and Locations More Information
| Study ID Numbers: | ACTG 032 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000731 History of Changes |
| Health Authority: | United States: Federal Government |
|
Acetaminophen Drug Interactions Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
|
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Anti-Retroviral Agents HIV Infections Analgesics, Non-Narcotic Sexually Transmitted Diseases Analgesics Peripheral Nervous System Agents Retroviridae Infections Acetaminophen |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Acetaminophen RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Analgesics, Non-Narcotic Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents |
