Mycobacterium Avium-intracellulare InfectionPhase 3NCT00002140
A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
A Phase 3 study testing Ethambutol hydrochloride, Clarithromycin and Azithromycin in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by Pfizer at 24 sites in United States.
Trial summary
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing… 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 Azithromycin
- How many people
- Not given
- Where
- 24 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
- Patients must have:
- HIV seropositivity.
- Disseminated MAC.
- No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).
- Life expectancy of at least 2 months.
- Consent of parent or guardian if below legal age of consent.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.
- Inability to take oral medications.
- Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).
- Concurrent Medication:
Show all 11Show fewer
- Excluded:
- Another investigational drug started in the week prior to study entry.
- Prior Medication:
- Excluded:
- MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
West Paces Clinical Research Inc
Atlanta, Georgia, 30327
Austin Infectious Disease Consultants
Austin, Texas, 78705
Central Texas Med Foundation
Austin, Texas, 78751
East Bay AIDS Ctr
Berkeley, California, 94705
Northwestern Univ Med School
Chicago, Illinois, 60611
Dr Neel French / Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Duke Univ Med Ctr
Durham, North Carolina, 27710
Pfizer Central Research
Groton, Connecticut, 06340
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, 77009
Dr Gary Brewton
Houston, Texas, 77027
Trinity Lutheran Hosp / Infectious Disease Clinic
Kansas City, Missouri, 64108
Med Service
Miami, Florida, 33125
Dr Milton Estes
Mill Valley, California, 94941
Oschner Clinic
New Orleans, Louisiana, 70121
Infectious Disease Med Group / Adult Immunology Clinic
Oakland, California, 94609
UCI Med Ctr
Orange, California, 92668
Kaiser Permanente Med Ctr
San Francisco, California, 94115
Santa Clara Valley Med Ctr
San Jose, California, 951282699
Dr Robert Wallace
St. Petersburg, Florida, 33713
Bay Area AIDS Consortium
Tampa, Florida, 33609
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009
About this study
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..
Read the detailed description
Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.
- Being tested
- Ethambutol hydrochloride, Clarithromycin, Azithromycin
- Keywords
- Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Azithromycin, 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
AzithromycinDrug
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 Mycobacterium Avium-intracellulare InfectionStudies 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
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002140
- Sponsor's protocol ID
- 226B
- Other IDs
- 066-189, 189/189B
- Status last verified
- Jul 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White AC Jr, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. doi: 10.1086/317468. Epub 2000 Nov 6.
PubMed 11073759
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, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
- ClinicalTrials.gov ID
- NCT00002140
- Acronym / sponsor ID
- 226B
- Keywords
- Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Azithromycin, Clarithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- 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.
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..
Detailed description
Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.
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 (6 listed)
- HIV seropositivity.
- Disseminated MAC.
- No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).
- Life expectancy of at least 2 months.
- Consent of parent or guardian if below legal age of consent.
Key exclusion criteria (11 listed)
- Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.
- Inability to take oral medications.
- Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).
- Another investigational drug started in the week prior to study entry.
- MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
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 | – |
| Azithromycin | 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.
- Background: PubMed 11073759Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White AC Jr, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. doi: 10.1086/317468. Epub 2000 Nov 6.
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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.
24 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 Azithromycin in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by Pfizer at 24 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 6 inclusion and 11 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 24 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 NCT00002140, 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.