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A Study of Azithromycin in HIV-Infected Patients



A Study of Azithromycin in HIV-Infected Patients

For Condition: Bacterial Infections,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients. The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.
Details: The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population. Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods.
Eligibility:
Study Type:  Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV seropositivity. - CD4 count <= 500 cells/mm3. - NO active AIDS opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Other active intercurrent illness. - Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies. - Signs or symptoms of severe illness that would preclude study participation. - Known allergies to macrolide antibiotics. Patients with the following prior condition are excluded: Clinically important change in baseline status 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: 12

Location and Contact Information:

Harris Laboratories Inc
Phoenix,  Arizona,  85040
United States
 


Additional Information:
Study ID Numbers:  226C;  066-060
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002344

Other Bacterial Infections Studies:
1. A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

2. Antibiotic treatment for patients with infections of short term in-dwelling vascular catheters due to a specific bacteria (gram positive bacteria)

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

4. A Study of Azithromycin in HIV-Infected Patients

5. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites

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