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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Oxazepam

U.S. FDA Resources

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

Additional 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
Study First Received:	November 2, 1999
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00000661 History of Changes
Health Authority:	United States: Federal Government

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

Oxazepam
Drug Evaluation
Drug Interactions
Zidovudine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neurotransmitter Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Hypnotics and Sedatives

Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Tranquilizing Agents
Immune System Diseases
Oxazepam
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections

ClinicalTrials.gov processed this record on November 09, 2009