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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002139
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
November 2, 1999
June 23, 2005
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No Changes Posted
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Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.
Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bacterial Infections
  • HIV Infections
Drug: Azithromycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002139
226D
066-062
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Pfizer
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NIH AIDS Clinical Trials Information Service
April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP