Mycobacterium Avium-intracellulare InfectionNCT00002032
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
A study testing Rifabutin in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by Pharmacia at 33 sites in United States.
Trial summary
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellulare Infection, HIV Infections
- What is being tested?
- Rifabutin
- How many people
- 750 participants
- Where
- 33 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the following:
- Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
- Written informed consent.
- Females of childbearing potential must also sign a special informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
- Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.
- Concurrent Medication:
- Excluded:
Show all 42Show fewer
- Antiretroviral agents other than zidovudine (AZT).
- Didanosine (ddI).
- Antimycobacterial therapy.
- Rifampin.
- Isoniazid.
- Clofazimine.
- Ethambutol.
- Cycloserine.
- Ethionamide.
- Amikacin.
- Ciprofloxacin.
- Streptomycin.
- Other investigational drugs.
- If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy.
- Patients with the following are excluded:
- Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
- Previous or current Mycobacterium avium complex (MAC) infection.
- Perceived patient unreliability or unavailability for frequent monitoring.
- Prior Medication:
- Excluded within 4 weeks of study entry:
- Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
- Antimycobacterial therapy.
- Rifampin.
- Isoniazid.
- Clofazimine.
- Ethambutol.
- Cycloserine.
- Ethionamide.
- Amikacin.
- Ciprofloxacin.
- Required:
- Zidovudine (AZT).
- Antipneumocystis prophylactic therapy.
- Required for at least 4 weeks prior to study entry:
- Zidovudine (AZT) or didanosine (ddI).
- Antipneumocystis prophylaxis.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Grady Memorial Hosp / Hughs Spalding Med Ctr
Atlanta, Georgia, 30335
Central Texas Med Foundation
Austin, Texas, 78751
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
CRI of New England
Brookline, Massachusetts, 02445
Brooklyn Veterans Administration
Brooklyn, New York, 11209
Maimonides Med Ctr
Brooklyn, New York, 11219
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ Med Ctr
Columbus, Ohio, 43210
Nelson Tebedo Community Clinic
Dallas, Texas, 75219
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Denver Public Health Dept
Denver, Colorado, 80204
Nassau County Med Ctr
East Meadow, New York, 11554
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905
Ctr for Special Immunology
Fort Lauderdale, Florida, 33308
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
Mem Hosp Hollywood
Hollywood, Florida, 33021
Baylor College of Medicine
Houston, Texas, 77005
Houston Clinical Research Network
Houston, Texas, 77266
Ctr for Special Immunology
Irvine, California, 92718
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Research Med Ctr
Kansas City, Missouri, 64132
Long Island Jewish Med Ctr
New Hyde Park, New York, 11042
Community Research Initiative
New York, New York, 10011
Chelsea Village Med Ctr
New York, New York, 10014
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, 32806
Dr Winkler Weinberg
Roswell, Georgia, 30076
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
Olive View Med Ctr
Sylmar, California, 91342
Scott and White Hosp
Temple, Texas, 76508
Dr Scott Lea
Waco, Texas, 76708
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
About this study
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.
- Being tested
- Rifabutin
- Keywords
- Rifabutin, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Antitubercular Agents
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 750 participants
Sponsor and investigators
- Lead sponsor
- Pharmacia
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002032
- Sponsor's protocol ID
- 048A
- Other IDs
- 087023-999
- Status last verified
- Jan 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.
PubMed 8807071Moore RD, Chaisson RE. Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS. 1995 Dec;9(12):1337-42. doi: 10.1097/00002030-199512000-00006.
PubMed 8605053
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
- Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00002032
- Acronym / sponsor ID
- 048A
- Keywords
- Rifabutin, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Antitubercular Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 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.
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
- Written informed consent.
- Females of childbearing potential must also sign a special informed consent.
Key exclusion criteria (42 listed)
- Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
- Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.
- Antiretroviral agents other than zidovudine (AZT).
- Didanosine (ddI).
- Antimycobacterial therapy.
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 |
|---|---|---|
| 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.
- Background: PubMed 8807071Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.
- Background: PubMed 8605053Moore RD, Chaisson RE. Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS. 1995 Dec;9(12):1337-42. doi: 10.1097/00002030-199512000-00006.
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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.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifabutin in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by Pharmacia at 33 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 4 inclusion and 42 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 33 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.
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 NCT00002032, which also lists 2 linked publications.
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.