Clinical Trial: Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

This study has been completed.

Sponsored by: Pfizer
Information provided by: AIDS Clinical Trials Information Service

Purpose

To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.

Condition Treatment or Intervention Phase
Bacterial Infections
HIV Infections
 Drug: Azithromycin
Phase I

MedlinePlus related topics:  AIDS;   Bacterial Infections

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

Further Study Details: 

Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

  • Antiretroviral agents, provided regimen has been stable for at least 1 month. Patients must have:
  • HIV infection.
  • CD4 count <= 200 cells/mm3.
  • No active opportunistic infection (pending discussion with Pfizer Clinician). Prior Medication: Allowed:
  • Prior antiretroviral agents.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

  • Active intercurrent illness (pending discussion with the Pfizer Clinician).
  • Allergies to macrolide antibiotics.
  • Signs and symptoms of severe illness that would preclude treatment.

Patients with the following prior conditions are excluded:

  • History of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
  • Clinically important change in baseline status within 4 weeks prior to study entry.
  • Condition affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies) within 4 weeks prior to study entry. Prior Medication: Excluded:
  • Investigational drugs including treatment IND drugs within 4 weeks prior to study entry. Known drug or alcohol dependence.

Location Information


Kansas
      Ctr for Phase I Research, Wichita,  Kansas,  67214,  United States

More Information

Study ID Numbers:  226D; 066-062
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002139
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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