A Study of Azithromycin in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
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.
Drug : Azithromycin
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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.
|Ages Eligible for Study:||18 Years to 65 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- HIV seropositivity.
- CD4 count <= 500 cells/mm3.
- NO active AIDS opportunistic infection.
- 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.
- Investigational drugs including treatment IND drugs within 4 weeks prior to study
Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded:
Clinically important change in baseline status within 4 weeks prior to study entry.
Known drug or alcohol dependence.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002344
Locations Show More
|United States, Arizona|
|Harris Laboratories Inc|
|Phoenix, Arizona, United States, 85040|
Sponsors and CollaboratorsPfizer
|ClinicalTrials.gov Identifier:||NCT00002344 History of Changes|
|Other Study ID Numbers:||226C|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Azithromycin
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on February 13, 2020
This information is provided by ClinicalTrials.gov.