Mycobacterium Avium-Intracellulare InfectionPhase 3NCT00002101
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
A Phase 3 study testing Ethambutol hydrochloride, Clarithromycin and Rifabutin in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Pharmacia at 44 sites in United States.
Trial summary
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. 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 Rifabutin
- How many people
- 450 participants
- Where
- 44 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Isoniazid for TB prophylaxis ONLY.
- Patients must have:
- HIV infection.
- MAC infection.
- Life expectancy of at least 16 weeks.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Perceived unreliability or unavailability for frequent monitoring.
- Concurrent Medication:
- Excluded:
- Antimycobacterial drugs other than the study drugs.
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- Carbamazepine.
- Terfenadine.
- Theophylline.
- Patients with the following prior condition are excluded:
- History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.
- Prior Medication:
- Excluded within 7 days prior to study entry:
- Rifabutin.
- Rifampin.
- Ethionamide.
- Cycloserine.
- Clofazimine.
- Ethambutol.
- Amikacin.
- Ciprofloxacin.
- Ofloxacin.
- Sparfloxacin.
- Azithromycin.
- Clarithromycin.
- Pyrazinamide.
- Excluded within 14 days prior to study entry:
- Carbamazepine.
- Terfenadine.
- Theophylline.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Infectious Disease Consultants
Altamonte Springs, Florida, 32701
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345
Central Texas Med Foundation
Austin, Texas, 78751
Charleston Veterans Administration Med Ctr
Charleston, South Carolina, 294015799
Nalle Clinic
Charlotte, North Carolina, 28207
Dr Daniel Berger
Chicago, Illinois, 60657
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
Dr Frank Tornaka
Fort Lauderdale, Florida, 33316
Gary Richmond MD
Fort Lauderdale, Florida, 33316
Bay Harbor Hosp
Harbor City, California, 90710
Polyclinic Med Ctr
Harrisburg, Pennsylvania, 17110
Dr Nelson Zide
Hollywood, Florida, 33021
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Ctr for Special Immunology
Irvine, California, 92718
Dr Arnold Markowitz
Keego Harbor, Michigan, 48320
Combat Group
Los Angeles, California, 90028
Cedars Sinai Med Ctr
Los Angeles, California, 90048
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792
Ctr for Special Immunology
Miami Beach, Florida, 33140
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
Long Island Jewish Med Ctr
New Hyde Park, New York, 11042
Tulane Univ Med School
New Orleans, Louisiana, 701122699
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, 10014
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
McDowell Clinic
Phoenix, Arizona, 85006
Maricopa Med Research Foundation
Phoenix, Arizona, 85008
Community Health Network
Rochester, New York, 14620
Dr Barry Rodwick
Safety Harbor, Florida, 34695
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
HIV Research Group
San Diego, California, 92102
UCSD / Ctr for Special Immunology
San Diego, California, 92103
Saint Francis Mem Hosp
San Francisco, California, 94109
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
Sunnyvale Med Clinic
Sunnyvale, California, 94086
Bay Area AIDS Consortium
Tampa, Florida, 33609
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
About this study
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
Read the detailed description
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.
- Being tested
- Ethambutol hydrochloride, Clarithromycin, Rifabutin
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, 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
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium-Intracellulare InfectionStudies of the same condition, open and under way.
- 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
- 450 participants
Sponsor and investigators
- Lead sponsor
- Pharmacia
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002101
- Sponsor's protocol ID
- 048D
- Other IDs
- CS 087250-999
- Status last verified
- Jun 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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 Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
- ClinicalTrials.gov ID
- NCT00002101
- Acronym / sponsor ID
- 048D
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Clarithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- PharmaciaIndustry (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.
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
Detailed description
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Isoniazid for TB prophylaxis ONLY.
- HIV infection.
- MAC infection.
- Life expectancy of at least 16 weeks.
Key exclusion criteria (30 listed)
- Perceived unreliability or unavailability for frequent monitoring.
- Antimycobacterial drugs other than the study drugs.
- Carbamazepine.
- Terfenadine.
- Theophylline.
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 | – |
| 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 24 Jun 2005.
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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.
44 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 Rifabutin in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Pharmacia at 44 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 7 inclusion and 30 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 44 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?
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.