Mycobacterium Avium-intracellular InfectionNCT00002331
The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
A study testing Ethambutol hydrochloride, Clarithromycin and Clofazimine in people with Mycobacterium Avium-intracellular Infection and HIV Infections, run by Abbott at 18 sites in 2 countries.
Trial summary
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellular Infection, HIV Infections
- What is being tested?
- Ethambutol hydrochloride, Clarithromycin and Clofazimine
- How many people
- Not given
- Where
- 18 sitesin 2 countries
- Study dates
- Jan 1994to Mar 1995
- Phase
- Interventional
- 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:
- History of HIV seropositivity.
- Disseminated MAC.
- Positive blood culture for MAC within 4 weeks prior to study entry.
- Consent of parent or guardian if less than 18 years of age.
- Ability to complete the study.
- NOTE:
- Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.
Who cannot join
- Concurrent Medication:
- Excluded:
- Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
- Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
- Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
- Amikacin.
Show all 27Show fewer
- Azithromycin.
- Capreomycin.
- Ciprofloxacin.
- Cycloserine.
- Ethionamide.
- Gentamicin.
- Kanamycin.
- Levofloxacin.
- Lomefloxacin.
- Ofloxacin.
- Rifampin.
- Rifabutin.
- Sparfloxacin.
- Streptomycin.
- Any other aminoglycosides, quinolones, and macrolides.
- Patients with the following prior conditions are excluded:
- History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.
- Prior Medication:
- Excluded:
- Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.
- Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Kaiser Permanente Med Ctr
Los Angeles, California, 90027
Dr Margaret Fischel
Miami, Florida, 33136
Vanderbilt Univ School of Medicine
Nashville, Tennessee, 37212
Tulane Univ Med School
New Orleans, Louisiana, 701122699
Beth Israel Med Ctr
New York, New York, 10003
Mount Sinai Med Ctr
New York, New York, 10029
Dr Stephen Hauptman
Philadelphia, Pennsylvania, 19107
UCD Med Ctr
Sacramento, California, 95817
Kaiser Permanente Med Ctr
San Francisco, California, 94115
Santa Clara Valley Med Ctr
San Jose, California, 951282699
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, 33614
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
Official title: A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).
SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.
- Being tested
- Ethambutol hydrochloride, Clarithromycin, Clofazimine
- Keywords
- Mycobacterium avium-intracellular Infection, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Clarithromycin
- Medical subject headings
- 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
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 startJan 1994
- Primary completionMar 1995
- Study completionMar 1995
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-intracellular 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002331
- Sponsor's protocol ID
- 214A
- Other IDs
- M93-069
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 16 Jan 2015
- Results posted
- No
Publications
Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. doi: 10.1097/00002030-199703110-00008.
PubMed 9147422
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS
- ClinicalTrials.gov ID
- NCT00002331
- Acronym / sponsor ID
- 214A
- Keywords
- Mycobacterium avium-intracellular Infection, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Clarithromycin
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 1994
- Primary completion
- Mar 1995 (actual)
- Study completion
- Mar 1995 (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.
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).
SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.
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 (8 listed)
- History of HIV seropositivity.
- Disseminated MAC.
- Positive blood culture for MAC within 4 weeks prior to study entry.
- Consent of parent or guardian if less than 18 years of age.
- Ability to complete the study.
Key exclusion criteria (27 listed)
- Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
- Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
- Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
- Amikacin.
- Azithromycin.
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 | – |
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 16 Jan 2015.
- Background: PubMed 9147422Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. doi: 10.1097/00002030-199703110-00008.
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.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethambutol hydrochloride, Clarithromycin and Clofazimine in people with Mycobacterium Avium-intracellular Infection and HIV Infections, run by Abbott at 18 sites in 2 countries.
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 8 inclusion and 27 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 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Puerto Rico. 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.
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 NCT00002331, 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 16 Jan 2015.