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

NCT00000661 | Completed Phase 1

• 1 other identifier: ACTG 124
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Oxazepam; Drug Evaluation; Drug Interactions; Zidovudine

Interventions

Oxazepam DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Palo Alto Veterans Adm Med Ctr / Stanford Univ

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• 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)

  BACKGROUND

• 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.

  PMID: 8417175 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Oxazepam; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Israelski D

  STUDY CHAIR

• Blaschke T

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: August 4, 2008

Record last verified: 1994-12

Locations

US (1)