The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000661
First received: November 2, 1999
Last updated: August 1, 2008
Last verified: December 1994
  Purpose

To determine if a pharmacokinetic (blood level) interaction exists between zidovudine (AZT) and oxazepam in the HIV-infected patient. Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection.


Condition Intervention Phase
HIV Infections
Drug: Oxazepam
Drug: Zidovudine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 8
Detailed Description:

Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection.

Patients are studied to determine oral and intravenous AZT and single oral dose oxazepam pharmacokinetics. Patients then take AZT and oxazepam together to determine if interactions between the drugs occur.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Required:

  • Stable prescribed dosage of zidovudine (AZT), = or > 500 mg/day.

Allowed:

  • Prophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine.
  • Erythropoietin.

Patients must be:

  • HIV positive by ELISA and Western blot.
  • Currently taking a stable prescribed dosage of 500 mg/day of zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or < 600 mg/day.
  • Significant underlying medical condition that could impair continuous participation in study.
  • Malabsorption syndrome (3 or more loose stools a day for at least 4 weeks associated with an unintentional weight loss of at least 10 percent of body weight).

Concurrent Medication:

Excluded:

  • Oral contraceptives.
  • Cytotoxic chemotherapy.
  • Ganciclovir.
  • Flucytosine.
  • Probenecid.
  • Opiates.
  • Valproic acid.
  • Sulfa drugs.
  • Sucralfate.
  • Dapsone.
  • Rifampin.
  • Antacids within 2 hours of zidovudine (AZT) dose.
  • Isoniazid.
  • Ketoconazole.
  • Pyrimethamine.
  • Clindamycin.
  • Aspirin.
  • Ibuprofen.
  • Investigational drugs not specifically allowed.

Patients with the following are excluded:

  • Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or < 600 mg/day.
  • Significant underlying medical condition that could impair continuous participation in study.
  • Unable to take oral medication reliably.

Prior Medication:

Excluded within 30 days of study entry:

  • Antiretroviral agents other than zidovudine (AZT).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000661

Locations
United States, California
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Investigators
Study Chair: Israelski D
Study Chair: Blaschke T
  More Information

Additional Information:
Publications:
Mole LA, Israelski DM, Bubp JL, O'Hanley P, Merigan T, Blaschke T. The pharmacokinetics (PK) of zidovudine (ZDV) and oxazepam (OXA) alone and in combination in the HIV-infected patient (ACTG 124). Int Conf AIDS. 1992 Jul 19-24;8(2):B186 (abstract no PoB 3595)

ClinicalTrials.gov Identifier: NCT00000661     History of Changes
Other Study ID Numbers: ACTG 124
Study First Received: November 2, 1999
Last Updated: August 1, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Oxazepam
Drug Evaluation
Drug Interactions
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Oxazepam
Zidovudine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014