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Evaluation of the Interaction Between Acetaminophen and Zidovudine

This study has been completed.
Study NCT00000731.   Last updated on July 29, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  Evaluation of the Interaction Between Acetaminophen and Zidovudine
Official Title  Evaluation of the Interaction Between Acetaminophen and Zidovudine
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.

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 Phase
Study Type  Interventional
Study Design  Treatment, Open Label, Pharmacokinetics Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Zidovudine
Drug: Acetaminophen
MEDLINE PMIDs 2024860
Links Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  10
Start Date 
Completion Date
Eligibility Criteria 

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.

Gender Both
Ages 18 Years to 50 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000731
Organization ID ACTG 032
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     Ptachcinski R        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date October 1991
First Received Date  November 2, 1999
Last Updated Date July 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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