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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

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 Treatment or Intervention Phase
HIV Infections
 Drug: Oxazepam
 Drug: Zidovudine
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study

Further Study Details: 

Expected Total Enrollment:  8

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 above,  Genders Eligible for Study:  Both

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).

Location Information


California
      Palo Alto Veterans Adm Med Ctr / Stanford Univ, Palo Alto,  California,  94304,  United States

Study chairs or principal investigators

Israelski D,  Study Chair
Blaschke T,  Study Chair

More Information

Click here for more information about Zidovudine

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)

Mole L, Israelski D, Bubp J, O'Hanley P, Merigan T, Blaschke T. Pharmacokinetics of zidovudine alone and in combination with oxazepam in the HIV infected patient. J Acquir Immune Defic Syndr. 1993 Jan;6(1):56-60.

Study ID Numbers:  ACTG 124
Record last reviewed:  December 1994
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000661
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources