Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.
Drug : Azithromycin
Masking: None (Open Label)
Primary Purpose: Treatment
|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:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Antiretroviral agents, provided regimen has been stable for at least 1 month.
- HIV infection.
- CD4 count <= 200 cells/mm3.
- No active opportunistic infection (pending discussion with Pfizer Clinician).
- Prior antiretroviral agents.
- Active intercurrent illness (pending discussion with the Pfizer Clinician).
- Allergies to macrolide antibiotics.
- Signs and symptoms of severe illness that would preclude treatment.
- 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.
- Investigational drugs including treatment IND drugs within 4 weeks prior to study
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Known drug or alcohol dependence.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002139
Locations Show More
|United States, Kansas|
|Ctr for Phase I Research|
|Wichita, Kansas, United States, 67214|
Sponsors and CollaboratorsPfizer
|ClinicalTrials.gov Identifier:||NCT00002139 History of Changes|
|Other Study ID Numbers:||226D|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on March 16, 2018
This information is provided by ClinicalTrials.gov.