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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Oxazepam Drug: Zidovudine	Phase I

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Oxazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

8

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000661

Locations


United States, California
	Palo Alto Veterans Adm Med Ctr / Stanford Univ
	Palo Alto, California, United States, 94304

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Study Chair:	Israelski D

Study Chair:	Blaschke T

More Information

Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site

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. 1993 Jan;6(1):56-60.

Study ID Numbers:	ACTG 124
First Received:	November 2, 1999
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00000661
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Oxazepam

Drug Evaluation

Drug Interactions

Zidovudine

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Oxazepam

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Neurotransmitter Agents

Slow Virus Diseases

Molecular Mechanisms of Pharmacological Action

GABA Modulators

Physiological Effects of Drugs

Psychotropic Drugs

Infection

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Hypnotics and Sedatives

Nucleic Acid Synthesis Inhibitors

RNA Virus Infections

Anti-HIV Agents

Tranquilizing Agents

Immune System Diseases

Central Nervous System Depressants

Enzyme Inhibitors

Antiviral Agents

Pharmacologic Actions

Lentivirus Infections

GABA Agents

Anti-Anxiety Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000661