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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000661

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

8

Last updated by the study team

2008-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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