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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Oxazepam Drug Evaluation Drug Interactions Zidovudine

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oxazepam

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Israelski D

Role: STUDY_CHAIR

Blaschke T

Role: STUDY_CHAIR

Locations

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Palo Alto Veterans Adm Med Ctr / Stanford Univ

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

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.