Search / Trial NCT00000661

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Oxazepam Drug Evaluation Drug Interactions Zidovudine

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.

Gender

All

Eligibility 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).

Attachments

readout_NCT00000661_2024-04-22.pdf

4.5 MB

NCT00000661_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Palo Alto, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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