Completed
Azithromycin Dose Proportionality Assessment in HIV-Infected Subjects
What is being tested
Azithromycin
Drug
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+10 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
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.
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.Design Details
12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsBacterial InfectionsHIV Infections
Criteria
3 inclusion criteria required to participate
CD4 count <= 500 cells/mm3
HIV seropositivity
NO active AIDS opportunistic infection
7 exclusion criteria prevent from participating
Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies
Clinically important change in baseline status within 4 weeks prior to study entry
Investigational drugs including treatment IND drugs within 4 weeks prior to study entry
Known allergies to macrolide antibiotics
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