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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS    Bacterial Infections   

ChemIDplus related topics:   Azithromycin   

U.S. FDA Resources

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.

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


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

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

Study placed in the following topic categories:
Virus Diseases
Bacterial Infections
Sexually Transmitted Diseases, Viral
HIV Infections
Azithromycin
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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