MycosesPhase 3NCT00002122
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
A Phase 3 study testing Azithromycin, Rifabutin and Fluconazole in people with Mycoses and Mycobacterium Avium-Intracellulare Infection, run by Pfizer at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mycoses, Mycobacterium Avium-Intracellulare Infection, HIV Infections
- What is being tested?
- Azithromycin, Rifabutin and Fluconazole
- How many people
- 720 participants
- Where
- 12 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 -
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235
Baylor College of Medicine
Houston, Texas, 77005
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCI Med Ctr
Orange, California, 92668
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, 92103
Santa Clara Valley Med Ctr
San Jose, California, 951282699
Harbor - UCLA Med Ctr
Torrance, California, 90509
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Being tested
- Azithromycin, Rifabutin, Fluconazole
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Mycoses, Drug Therapy, Combination, Fluconazole, Acquired Immunodeficiency Syndrome, Azithromycin
- Medical subject headings
- Mycoses, Mycobacterium avium-intracellulare Infection, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
RifabutinDrug
FluconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MycosesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 720 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002122
- Sponsor's protocol ID
- 226A
- Other IDs
- 066-174
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00002122
- Acronym / sponsor ID
- 226A
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Mycoses, Drug Therapy, Combination, Fluconazole, Acquired Immunodeficiency Syndrome, Azithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Preventive therapy with isoniazid for M. tuberculosis.
- Maintenance therapy for CMV retinitis.
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin | Drug | – |
| Rifabutin | Drug | – |
| Fluconazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundHavlir 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin, Rifabutin and Fluconazole in people with Mycoses and Mycobacterium Avium-Intracellulare Infection, run by Pfizer at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.