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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

August 1, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000661 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Pharmacokinetics Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Oxazepam
Drug: Zidovudine

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000661

Responsible Party

Study ID Numbers ^ICMJE

ACTG 124

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Israelski D
Study Chair:	Blaschke T

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

December 1994

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP