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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 8

Location and Contact Information:

Overall Study Official:
IsraelskiD,  Study Chair, 

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


Additional Information:
Study ID Numbers:
  ACTG 124; 
Study Start Date: 
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000661

Other Hiv Infections Studies:
1. A Comparison of Epivir Plus Crixivan Combined with Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

2. A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

3. The Safety and Effectiveness of BI-RG-587 in HIV-Infected Patients

4. Adding New Drugs for HIV Infected Patients Failing Current Therapy

5. A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

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

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