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

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ClinicalTrials.gov Identifier: NCT00000661
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 4, 2008
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Oxazepam Drug: Zidovudine Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 8 participants
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000661


Locations
United States, California
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, United States, 94304
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Israelski D
Study Chair: Blaschke T

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
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: December 1994

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

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