Mycobacterium Avium-Intracellulare InfectionNCT00002037
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
A study testing Trifluridine in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Amgen at 1 site in United States.
Trial summary
To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. 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?
- Trifluridine
- How many people
- 15 participants
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia.
- Life expectancy of at least 3 months.
- Baseline chest X-ray and EKG (electrocardiogram).
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Known hypersensitivity to interferons or other exogenous lymphokine.
- History of cardiac abnormality or disease.
- History of hypertension.
- Patients with the following are excluded:
Show all 21Show fewer
- Known hypersensitivity to interferons or other exogenous lymphokine.
- History of cardiac abnormality or disease.
- History of hypertension.
- Prior Medication:
- Excluded within 4 weeks of study entry:
- Corticosteroids.
- Anti-inflammatory medication (except aspirin).
- Changes in the dose of anti-mycobacterial drugs.
- Immune agents.
- Prior Treatment:
- Excluded within 4 weeks of study entry:
- Radiotherapy.
- Risk Behavior:
- Excluded:
- Intravenous drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Hosp - Cornell Med Ctr
New York, New York, 10021
About this study
To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.
- Being tested
- Trifluridine
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Interferon-gamma, Recombinant, Acquired Immunodeficiency Syndrome
- 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.
TrifluridineDrug
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.
- Other trials for Mycobacterium Avium-Intracellulare InfectionStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002037
- Sponsor's protocol ID
- 062B
- Other IDs
- IFNG-8701
- Status last verified
- May 1991
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
- ClinicalTrials.gov ID
- NCT00002037
- Acronym / sponsor ID
- 062B
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Interferon-gamma, Recombinant, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- AmgenIndustry (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 examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 and persistent Mycobacterium avium- intracellulare (MAI) bacillemia.
- Life expectancy of at least 3 months.
- Baseline chest X-ray and EKG (electrocardiogram).
Key exclusion criteria (21 listed)
- Known hypersensitivity to interferons or other exogenous lymphokine.
- History of cardiac abnormality or disease.
- History of hypertension.
- Known hypersensitivity to interferons or other exogenous lymphokine.
- History of cardiac abnormality or disease.
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 |
|---|---|---|
| Trifluridine | 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.
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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 Trifluridine in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Amgen 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 4 inclusion and 21 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?
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.