Evaluation of the Interaction Between Acetaminophen and Zidovudine

NCT00000731 | Completed

• 2 other identifiers: ACTG 03211008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Acetaminophen; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine

Interventions

Zidovudine DRUG

Acetaminophen DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Univ of Pittsburgh Med School

Pittsburgh, Pennsylvania, United States

Location

Related Publications (4)

• 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)

  BACKGROUND

• 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)

  BACKGROUND

• 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. doi: 10.7326/0003-4819-114-11-937.

  PMID: 2024860 BACKGROUND

• 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)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zidovudine; Acetaminophen

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ptachcinski R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: May 1, 1990
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)