The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Oxazepam (Drug); Zidovudine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Israelski D, Study Chair Blaschke T, Study Chair
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.
Clinical Details
Official title: The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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).
Locations and Contacts
Palo Alto Veterans Adm Med Ctr / Stanford Univ, Palo Alto, California 94304, United States
Additional Information
Click here for more information about Zidovudine
Related 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.
Last updated: August 1, 2008
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