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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxazepam
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Oxazepam, Drug Evaluation, Drug Interactions, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Palo Alto Veterans Adm Med Ctr / Stanford Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
August 1, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000661
Brief Title
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
Official Title
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
Study Type
Interventional

2. Study Status

Record Verification Date
December 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Oxazepam, Drug Evaluation, Drug Interactions, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
8 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxazepam
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israelski D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Blaschke T
Official's Role
Study Chair
Facility Information:
Facility Name
Palo Alto Veterans Adm Med Ctr / Stanford Univ
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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PubMed Identifier
8417175
Citation
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.
Results Reference
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The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient

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