DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections; HIV Infections

Intervention: Azithromycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Summary

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

Clinical Details

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

Study design: Treatment, Open Label, Pharmacokinetics Study

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Ctr for Phase I Research, Wichita, Kansas 67214, United States
Additional Information


Last updated: June 23, 2005

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2009