Mycobacterium Avium-intracellulare InfectionPhase 3NCT00001047
Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
A Phase 3 study testing Ethambutol hydrochloride, Clarithromycin and Clofazimine in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in United States.
Trial summary
To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellulare Infection, HIV Infections
- What is being tested?
- Ethambutol hydrochloride, Clarithromycin and Clofazimine
- How many people
- 400 participants
- Where
- 16 sitesUnited States
- Study dates
- Start not givento Aug 1996
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Recommended in patients with CD4 count <= 200 cells/mm3:
- Antiretroviral therapy.
- PCP prophylaxis.
- Allowed in all patients:
- Isoniazid preventive therapy.
Show all 11Show fewer
- Patients must have:
- HIV infection.
- Evidence of disseminated MAC infection.
- NOTE:
- Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity to the study drugs.
- Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.
- Concurrent Medication:
- Excluded:
- Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).
- Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Partners Research
Albuquerque, New Mexico, 871315271
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Baltimore Trials
Baltimore, Maryland, 21201
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
Richmond AIDS Consortium
Richmond, Virginia, 23298
Community Consortium of San Francisco
San Francisco, California, 94110
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
About this study
Official title: An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)
To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients.
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
Read the detailed description
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.
- Being tested
- Ethambutol hydrochloride, Clarithromycin, Clofazimine, Rifabutin
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Clarithromycin
- Medical subject headings
- 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.
Ethambutol hydrochlorideDrug
ClarithromycinDrug
ClofazimineDrug
RifabutinDrug
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)
- Study completionAug 1996
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 Mycobacterium Avium-intracellulare InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Enrolment
- 400 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Cohn D, Study chairFisher E, Study chairHorsburgh CR, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001047
- Sponsor's protocol ID
- CPCRA 027
- Other IDs
- 11577
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Cohn DL, Fisher EJ, Peng GT, Hodges JS, Chesnut J, Child CC, Franchino B, Gibert CL, El-Sadr W, Hafner R, Korvick J, Ropka M, Heifets L, Clotfelter J, Munroe D, Horsburgh CR Jr. A prospective randomized trial of four three-drug regimens in the treatment of disseminated Mycobacterium avium complex disease in AIDS patients: excess mortality associated with high-dose clarithromycin. Terry Beirn Community Programs for Clinical Research on AIDS. Clin Infect Dis. 1999 Jul;29(1):125-33. doi: 10.1086/520141.
PubMed 10433575
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)
- ClinicalTrials.gov ID
- NCT00001047
- Acronym / sponsor ID
- CPCRA 027
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Clarithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Aug 1996 (actual)
- 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.
To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients.
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
Detailed description
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Antiretroviral therapy.
- PCP prophylaxis.
- Isoniazid preventive therapy.
- HIV infection.
- Evidence of disseminated MAC infection.
Key exclusion criteria (8 listed)
- Known hypersensitivity to the study drugs.
- Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.
- Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).
- Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., 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 |
|---|---|---|
| Ethambutol hydrochloride | Drug | – |
| Clarithromycin | Drug | – |
| Clofazimine | Drug | – |
| Rifabutin | 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 4 Nov 2021.
- Background: PubMed 10433575Cohn DL, Fisher EJ, Peng GT, Hodges JS, Chesnut J, Child CC, Franchino B, Gibert CL, El-Sadr W, Hafner R, Korvick J, Ropka M, Heifets L, Clotfelter J, Munroe D, Horsburgh CR Jr. A prospective randomized trial of four three-drug regimens in the treatment of disseminated Mycobacterium avium complex disease in AIDS patients: excess mortality associated with high-dose clarithromycin. Terry Beirn Community Programs for Clinical Research on AIDS. Clin Infect Dis. 1999 Jul;29(1):125-33. doi: 10.1086/520141.
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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.
Cohn D study chair
Fisher E study chair
Horsburgh CR study chair
16 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 Ethambutol hydrochloride, Clarithromycin and Clofazimine in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 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 8 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 NCT00001047, 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 4 Nov 2021.