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A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

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NCT00002122

Last updated on November 20, 2019
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FOR MORE INFORMATION
Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycoses, Mycobacterium Avium-Intracellulare Infection, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Concurrent Medication:

Allowed:

- Preventive therapy with isoniazid for M. tuberculosis.

- Maintenance therapy for CMV retinitis.

Patients must have:

- HIV infection or history of an AIDS-defining condition by CDC criteria.

- One documented CD4 count

- NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous
or nontuberculous).

- NO acute opportunistic infection.

- Life expectancy of more than 6 months.

- Consent of parent or guardian if less than legal age of consent.

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:

ALL PATIENTS -

- Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver
function tests, or odynophagia for which the diagnoses of MAC and fungal infections
have not been excluded.

- Serious hypersensitivity reactions to macrolides or rifampin.

- Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION -

- Serious hypersensitivity reaction to fluconazole.

- Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis,
Candida esophagitis, thrush, vaginal candidiasis).

- Positive baseline urine cryptococcal culture.

Concurrent Medication:

Excluded for fluconazole randomization:

- Maintenance therapy for deep fungal infections.

- Chronic therapy with ketoconazole or fluconazole.

NCT00002122
Pfizer
Completed
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

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Descriptive Information
Brief Title  ICMJE A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
Official Title  ICMJE A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
Brief Summary

PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population.

SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.

Detailed DescriptionPatients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Mycoses
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
Intervention  ICMJE
  • Drug: Azithromycin
  • Drug: Rifabutin
  • Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications *Havlir DV, Mccutchan JA, Bozzette SA, Dunne M. A double-blind, randomized study of weekly azithromycin, daily rifabutin, and combination azithromycin and rifabutin for the prevention of Mycobactetum avium complex (MAC) 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
 (submitted: June 23, 2005)		720
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Preventive therapy with isoniazid for M. tuberculosis.
  • Maintenance therapy for CMV retinitis.

Patients must have:

  • HIV infection or history of an AIDS-defining condition by CDC criteria.
  • One documented CD4 count < 100 cells/mm3 within 12 months prior to study entry.
  • NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous).
  • NO acute opportunistic infection.
  • Life expectancy of more than 6 months.
  • Consent of parent or guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

ALL PATIENTS -

  • Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded.
  • Serious hypersensitivity reactions to macrolides or rifampin.
  • Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION -
  • Serious hypersensitivity reaction to fluconazole.
  • Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis).
  • Positive baseline urine cryptococcal culture.

Concurrent Medication:

Excluded for fluconazole randomization:

  • Maintenance therapy for deep fungal infections.
  • Chronic therapy with ketoconazole or fluconazole.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, 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 NCT00002122
Other Study ID Numbers  ICMJE 226A
066-174
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

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