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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

Page last updated: August 23, 2015

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