A Study of Azithromycin in HIV-Infected Patients

NCT00002344

Last updated date
Study Location
Harris Laboratories Inc
Phoenix, Arizona, 85040, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients must have:

- HIV seropositivity.

- CD4 count <= 500 cells/mm3.

- NO active AIDS opportunistic infection.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Azithromycin in HIV-Infected Patients
Official Title  ICMJE Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Infections
  • HIV Infections
Intervention  ICMJE Drug: Azithromycin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002344
Other Study ID Numbers  ICMJE 226C
066-060
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date April 1996

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