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
NCT00002122
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Adult Trials: 18+ Years
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.
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.
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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 Description | Patients 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 |
| ||
| Intervention ICMJE |
| ||
| 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 | 720 | ||
| Original Enrollment ICMJE | Same as current | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: ALL PATIENTS -
Concurrent Medication: Excluded for fluconazole randomization:
| ||
| Sex/Gender ICMJE |
| ||
| 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 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 | |||