Mycobacterium Avium-intracellulare InfectionNCT00002080
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study
A study testing Rifabutin in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by Pharmacia at 1 site in United States.
Trial summary
Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin. Secondary: To further characterize the safety of rifabutin monotherapy in preventing or delaying MAC bacteremia in HIV positive patients with CD4 counts =… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellulare Infection, HIV Infections
- What is being tested?
- Rifabutin
- How many people
- Not given
- Where
- 1 siteUnited 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Any medication with the exception of other investigational drugs not available under a treatment IND, expanded access, or parallel track program.
- Patients must have:
- Confirmed HIV infection.
- CD4 cell counts <= 200 cells/mm3.
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- No evidence of disseminated MAC disease.
- Informed consent of parent or guardian if 12 to < 18 years of age.
- NOTE:
- Pregnant females may be eligible. There are no studies of the safety or efficacy of rifabutin in pregnant women. Rifabutin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In addition, a risk/benefit decision should consider the likelihood of a woman's developing MAC if she does not receive prophylaxis. The risk of developing MAC rises substantially for women with CD4 counts less than 100, although it can also develop in women with higher CD4 counts. Women of reproductive potential who are not pregnant must use contraception. They are encouraged to use means other than oral contraceptives.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Known hypersensitivity to rifabutin, rifampin, or other rifamycins.
- Current infection due to MAC or other mycobacterial disease, or complaints consistent with tuberculosis.
- Concurrent Medication:
- Excluded:
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- Other investigational drugs with the exception of those available under a treatment IND, expanded access, or parallel track program. (Licensed products prescribed for unlabeled indications are not considered investigational.)
- Patients with the following prior conditions are excluded:
- Prior infection due to MAC or other mycobacterial disease or complaints consistent with tuberculosis.
Trial locations and contacts
1 site in 1 country.
About this study
Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin.
Secondary: To further characterize the safety of rifabutin monotherapy in preventing or delaying MAC bacteremia in HIV positive patients with CD4 counts = or < 200.
- Being tested
- Rifabutin
- Keywords
- Rifabutin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium avium Complex, Bacteremia
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Bacteremia
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
Sponsor and investigators
- Lead sponsor
- Pharmacia
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002080
- Sponsor's protocol ID
- 109A
- Other IDs
- 087085-999
- Status last verified
- Apr 2003
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Gordin F, Masur H. Prophylaxis of Mycobacterium avium complex bacteremia in patients with AIDS. Clin Infect Dis. 1994 Apr;18 Suppl 3:S223-6. doi: 10.1093/clinids/18.supplement_3.s223.
PubMed 8204774
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 HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study
- ClinicalTrials.gov ID
- NCT00002080
- Acronym / sponsor ID
- 109A
- Keywords
- Rifabutin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium avium Complex, Bacteremia
- Study type
- Interventional
- Recruitment status
- Completed
- 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.
Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin.
Secondary: To further characterize the safety of rifabutin monotherapy in preventing or delaying MAC bacteremia in HIV positive patients with CD4 counts = or < 200.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Any medication with the exception of other investigational drugs not available under a treatment IND, expanded access, or parallel track program.
- Confirmed HIV infection.
- CD4 cell counts <= 200 cells/mm3.
- No evidence of disseminated MAC disease.
- Informed consent of parent or guardian if 12 to < 18 years of age.
Key exclusion criteria (9 listed)
- Known hypersensitivity to rifabutin, rifampin, or other rifamycins.
- Current infection due to MAC or other mycobacterial disease, or complaints consistent with tuberculosis.
- Other investigational drugs with the exception of those available under a treatment IND, expanded access, or parallel track program. (Licensed products prescribed for unlabeled indications are not considered investigational.)
- Prior infection due to MAC or other mycobacterial disease or complaints consistent with tuberculosis.
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 8204774Gordin F, Masur H. Prophylaxis of Mycobacterium avium complex bacteremia in patients with AIDS. Clin Infect Dis. 1994 Apr;18 Suppl 3:S223-6. doi: 10.1093/clinids/18.supplement_3.s223.
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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.
1 site 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 1 site 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 10 inclusion and 9 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 1 site 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 NCT00002080, 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.