Evaluation of the Interaction Between Acetaminophen and Zidovudine
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Zidovudine (Drug); Acetaminophen (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Ptachcinski R, Study Chair
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.
Clinical Details
Official title: Evaluation of the Interaction Between Acetaminophen and Zidovudine
Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Univ of Pittsburgh Med School, Pittsburgh, Pennsylvania, United States
Additional Information
Click here for more information about Zidovudine
Related publications: Steffe E, Inciardi J, King J, Flynn N, Goldstein E, Tanjes T. Analysis of the effect of acetaminophen on zidovudine pharmacokinetics in HIV infected patients. Int Conf AIDS. 1989 Jun 4-9;5:560 (abstract no MCP113) Koda RT, Ko RJ, Antoniskis D, Shields M, Melancon H, Cohen JL, Leedom JM, Sattler FR. Effect of acetaminophen (ACET) on the pharmacokinetics of zidovudine (AZT). Int Conf AIDS. 1989 Jun 4-9;5:203 (abstract no WBO5) Sattler FR, Ko R, Antoniskis D, Shields M, Cohen J, Nicoloff J, Leedom J, Koda R. Acetaminophen does not impair clearance of zidovudine. Ann Intern Med. 1991 Jun 1;114(11):937-40. Pazin GJ, Ptachcinski RJ, Sheehan M, Ho M. Interactive pharmacokinetics of zidovudine and acetaminophen. Int Conf AIDS. 1989 Jun 4-9;5:278 (abstract no MBP338)
Last updated: March 15, 2012
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