Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
Completed · Phase 1
Conditions studied: Bacterial Infections, HIV Infections
In brief
To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.
Key facts
- Study ID
- NCT00002139
- Run by
- Pfizer
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ctr for Phase I Research — Wichita, Kansas, United States
Full record on ClinicalTrials.gov
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