You are here

A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients

Last updated on November 9, 2019

FOR MORE INFORMATION
Study Location
San Diego Naval Hosp
San Diego, California, 921345000 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Concurrent Medication:

Required:

- Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or
without dihydrofolate reductase inhibitors, pentamidine).

Allowed:

- Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including
azoles).

Patients must have:

- HIV infection.

- CD4 count

- No MAC positive blood cultures within 1 month prior to study entry.

- No symptoms suggestive of disseminated MAC infection (including unexplained diarrhea,
fever, and night sweats) within 1 month of study entry.

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:

- Positive PPD within 3 months prior to study entry (negative PPD defined as induration).

- Chest x-ray suggestive of any active disease, in particular tuberculosis.

- Known hypersensitivity to macrolide antibiotics.

- Any other acute clinical condition likely to interfere with completion of the
protocol.

- Inability to care for self without considerable assistance and medical care.

Concurrent Medication:

Excluded:

- Other investigational new drugs (except for foscarnet or ddC) unless prior agreement
has been reached between the investigator and the Pfizer project physician.

- Concomitant putative immunostimulants.

Patients with the following prior conditions are excluded:

History of MAC or Mycobacterium tuberculosis (MTb) infection.

Prior Medication:

Excluded within the past 4 weeks:

- Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine,
ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones
thought to be active against MAC.

NCT00002309
Pfizer
Completed
A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Azithromycin as Prophylaxis Against the Development of Mycobacterium Avium Complex Disease in HIV-Infected People
Brief SummaryTo evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised HIV-infected patients with a CD4 count < 100 cells/mm3.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
Intervention  ICMJE Drug: Azithromycin
Study Arms  ICMJE Not Provided
Publications *Oldfield EC, Dickinson G, Chung R, Wallace MR, Craig DB, Fessel WJ, Joyce MP, Mckee KT, Melcher G, Wagner KF, Williams WJ, Zajdowicz M, Heifits L, Dunne MW, Berman J. Once weekly azithromycin for the prevention of Mycobacterium avium complex (MAC) infection in AIDS patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:90


*   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 Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Concurrent Medication:

Required:

  • Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine).

Allowed:

  • Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles).

Patients must have:

  • HIV infection.
  • CD4 count < 100 cells/mm3.
  • No MAC positive blood cultures within 1 month prior to study entry.
  • No symptoms suggestive of disseminated MAC infection (including unexplained diarrhea, fever, and night sweats) within 1 month of study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Positive PPD within 3 months prior to study entry (negative PPD defined as < 5 mm induration).
  • Chest x-ray suggestive of any active disease, in particular tuberculosis.
  • Known hypersensitivity to macrolide antibiotics.
  • Any other acute clinical condition likely to interfere with completion of the protocol.
  • Inability to care for self without considerable assistance and medical care.

Concurrent Medication:

Excluded:

  • Other investigational new drugs (except for foscarnet or ddC) unless prior agreement has been reached between the investigator and the Pfizer project physician.
  • Concomitant putative immunostimulants.

Patients with the following prior conditions are excluded:

History of MAC or Mycobacterium tuberculosis (MTb) infection.

Prior Medication:

Excluded within the past 4 weeks:

  • Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine, ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones thought to be active against MAC.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 NCT00002309
Other Study ID Numbers  ICMJE 058I
066-155
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateApril 1996

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now