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



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

For Condition: Bacterial Infections,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.
Details: Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.
Eligibility:
Study Type:
  Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

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


Additional Information:
Study ID Numbers:
  226D;  066-062
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002139

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2. New antibiotic to treat pediatric patients with infections due to a specific bacteria (Vancomycin-Resistant Enterococcus)

3. A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

4. Phase II Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Mucoid Exopolysaccharide Pseudomonas Aeruginosa Immune Globulin for Cystic Fibrosis

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