Clinical Trials

MainTitle

A Study of Azithromycin in HIV-Infected Patients

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002344

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Bacterial Infections
HIV Infections

Drug : Azithromycin
Phase 1

Study Type: Interventional
Study Design: 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:

Enrollment: 12

Detailed Description:

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

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing 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

United States, Arizona
Harris Laboratories Inc
Phoenix, Arizona, United States, 85040

Sponsors and Collaborators

Pfizer
More Information

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002344   History of Changes  
Other Study ID Numbers: 226C  
  066-060  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Azithromycin
Bacterial Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Bacterial Infections

ClinicalTrials.gov processed this data on December 12, 2017
This information is provided by ClinicalTrials.gov.