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Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002139
  Purpose

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


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

Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study
Official Title: Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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 to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002139

Locations
United States, Kansas
Ctr for Phase I Research
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

Study ID Numbers: 226D, 066-062
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002139     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Azithromycin
Bacterial Infections

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
HIV Infections
Therapeutic Uses
Azithromycin
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010