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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

Last updated on March 15, 2019

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Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
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.
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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.
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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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