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A Study of Azithromycin in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002344
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002344 on ClinicalTrials.gov Archive Site
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A Study of Azithromycin in HIV-Infected Patients
Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects

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.

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.

Interventional
Phase 1
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Bacterial Infections
  • HIV Infections
Drug: Azithromycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002344
226C, 066-060
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Pfizer
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NIH AIDS Clinical Trials Information Service
April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP