Status:
COMPLETED
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 p...
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 t...
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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00000661
Last Update
August 4 2008
Active Locations (1)
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1
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, United States, 94304