- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000661
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
Study Overview
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
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- Palo Alto Veterans Adm Med Ctr / Stanford Univ
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
Collaborators and Investigators
Investigators
- Study Chair: Israelski D
Publications and helpful links
General 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 (1988). 1993 Jan;6(1):56-60.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Zidovudine
- Oxazepam
Other Study ID Numbers
- ACTG 124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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