Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects. - Article
Clinical Trial: Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
This study has been completed.
To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.
|Condition||Treatment or Intervention||Phase|
|Bacterial Infections |
| Drug: Azithromycin ||Phase I |
MedlinePlus related topics: AIDS; Bacterial Infections
Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study
Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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.
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.
Ctr for Phase I Research, Wichita, Kansas, 67214, United States
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
Cache Date: April 9, 2005
- Birds, Infections from (Centers for Disease Control and Prevention)