Evaluation of the Interaction Between Acetaminophen and Zidovudine

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000731
Collaborator
(none)
10
1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Interaction Between Acetaminophen and Zidovudine
Actual Study Completion Date :
May 1, 1990

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Exclusion Criteria

    Co-existing Condition:
    Patients with the following are excluded:
    • Severe ongoing opportunistic infection including Pneumocystis carinii pneumonia (PCP), cryptococcal or toxoplasmosis meningoencephalitis, disseminated herpes simplex or herpes zoster. A demonstrated prior sensitivity or an experience of significant adverse effects during prior therapy with the drug to be used in the study.

    • Significant diarrhea at entry ( > 1 watery stool/day).

    Patients with the following are excluded:
    • Severe ongoing opportunistic infection including Pneumocystis carinii pneumonia (PCP), cryptococcal or toxoplasmosis meningoencephalitis, disseminated herpes simplex or herpes zoster. A demonstrated prior sensitivity or an experience of significant adverse effects during prior therapy with the drug to be used in the study.

    • Significant diarrhea at entry ( > 1 watery stool/day).

    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:
    • Fever of > 38.5 degrees C persisting for longer than 3 weeks.

    • Involuntary weight loss of > 15 lbs. or > 10 percent of baseline noted in a 120-day period prior to evaluation.

    • History of diarrhea (> 2 liquid stools per day) persisting for longer than 1 month but not occurring at entry.

    • History of clinical diagnosis of oral candidiasis or hairy leukoplakia. Patients who have AIDS-defined opportunistic infections or tumors.

    • Patients eligible for zidovudine under the labeling. A positive HIV antibody test. Exceptions will be made for patients with a previously positive HIV antibody test with progressive disease and patients where virus isolation has been made. A life expectancy of at least 3 months.

    • Patients with stable Kaposi's sarcoma, mild herpes infections, mild or stable depression, asymptomatic or mild cytomegalovirus or Epstein-Barr virus infection, or a hepatitis B virus carrier state will be acceptable for study.

    Inability to abstain from alcohol or any other drug, including nonprescription medications, during the study period.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univ of Pittsburgh Med School Pittsburgh Pennsylvania United States

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: Ptachcinski R,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00000731
    Other Study ID Numbers:
    • ACTG 032
    • 11008
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021