Completed
Azithromycin Clinical Pharmacology in HIV-Infected Subjects' Buffy Coat
What is being tested
Azithromycin
Drug
Who is being recruted
Blood-Borne Infections+15
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeBacterial InfectionsHIV Infections
Criteria
5 inclusion criteria required to participate
Antiretroviral agents, provided regimen has been stable for at least 1 month
CD4 count <= 200 cells/mm3
HIV infection
No active opportunistic infection (pending discussion with Pfizer Clinician)
Show More Criteria
8 exclusion criteria prevent from participating
Active intercurrent illness (pending discussion with the Pfizer Clinician)
Allergies to macrolide antibiotics
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
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center