Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

HIV Infections Clinical Trial

Official title:

Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002139
• Other study ID #: 226D
• Secondary ID: 066-062
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.

Description:

Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• Azithromycin

Locations

Country	Name	City	State
United States	Ctr for Phase I Research	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,