Mycobacterium Avium-Intracellulare InfectionNCT00001995
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
A study testing Rifabutin in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Pharmacia at 22 sites in United States.
Trial summary
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen. 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
- 200 participants
- Where
- 22 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
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- Didanosine (ddI).
- Patients must have the following:
- Diagnosis of AIDS as defined by the CDC.
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- Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
- Provide written informed consent.
- Prior Medication:
- Allowed:
- If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
- Required:
- Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Known hypersensitivity to any of the study drugs.
- Concurrent Medication:
- Excluded:
- Other therapy for mycobacterial disease.
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- Patients with the following are excluded:
- Known hypersensitivity to any of the study drugs.
- Prior Medication:
- Excluded within 4 weeks:
- Therapy for mycobacterial disease.
- Antiretroviral drugs, other than zidovudine (AZT) or ddI.
- Investigational drugs, other than ddI.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30076
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
Nassau County Med Ctr
East Meadow, New York, 11554
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
Ctr for Special Immunology
Fort Lauderdale, Florida, 33316
Bay Harbor Hosp
Harbor City, California, 90710
Mem Hosp Hollywood
Hollywood, Florida, 33021
Ctr for Special Immunology
Irvine, California, 92718
Research Med Ctr
Kansas City, Missouri, 64132
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90028
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
Dr Frank Rhame
Minneapolis, Minnesota, 55455
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, 10014
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
Maricopa County Med Ctr
Phoenix, Arizona, 85010
AIDS Community Research Consortium
Redwood City, California, 94063
HIV Research Group
San Diego, California, 92102
Davies Med Ctr
San Francisco, California, 94114
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
About this study
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.
- Being tested
- Rifabutin
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome
- 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.
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 (1)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
- 200 participants
Sponsor and investigators
- Lead sponsor
- Pharmacia
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001995
- Sponsor's protocol ID
- 048C
- Other IDs
- CS 087065
- Status last verified
- Nov 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 8807071
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 Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
- ClinicalTrials.gov ID
- NCT00001995
- Acronym / sponsor ID
- 048C
- Keywords
- Rifabutin, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 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 determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.
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 (13 listed)
- Zidovudine (AZT).
- Didanosine (ddI).
- Diagnosis of AIDS as defined by the CDC.
- Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
- Provide written informed consent.
Key exclusion criteria (13 listed)
- Known hypersensitivity to any of the study drugs.
- Other therapy for mycobacterial disease.
- Known hypersensitivity to any of the study drugs.
- Therapy for mycobacterial disease.
- Antiretroviral drugs, other than zidovudine (AZT) or ddI.
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.
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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.
22 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 22 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 13 inclusion and 13 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 22 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 NCT00001995, 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.