Mycobacterium Avium-Intracellulare InfectionPhase 1NCT00002104
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
A Phase 1 study testing Thalidomide in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Aaron Diamond AIDS Research Center at 2 sites in United States.
Trial summary
To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection
- What is being tested?
- Thalidomide
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE:
- HIV-positive patients must have CD4 count < 500 cells/mm3 and be on antiretroviral therapy.
- One of the following manifestations:
- Temperature over 38 C on at least two occasions in the week prior to study entry.
- Recent weight loss of more than 5 kilograms.
Show all 10Show fewer
- Pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to HIV status.
- Night sweats on two or more occasions in the week prior to study entry.
- NOTE:
- Patients must be hospitalized men aged 18-65 and postmenopausal women to age 65. Anticipated requirement for hospitalization must be at least 10 days.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Neuropathy or other disorders with risk of neuropathy.
- Required for HIV-positive patients if CD4 count < 500 cells/mm3:
- Antiretroviral therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Hosp Ctr
New York, New York, 10016
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021
About this study
To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.
Read the detailed description
Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are followed for 28 days. Patients are stratified according to HIV status and stage of HIV infection.
- Conditions
- Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection
- Being tested
- Thalidomide
- Keywords
- Mycobacterium tuberculosis, Mycobacterium Infections, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium Infections, Atypical, Thalidomide
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
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.
- 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Aaron Diamond AIDS Research Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002104
- Sponsor's protocol ID
- 133A
- Status last verified
- Jul 1998
- 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
- Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
- ClinicalTrials.gov ID
- NCT00002104
- Acronym / sponsor ID
- 133A
- Conditions
- Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection
- Keywords
- Mycobacterium tuberculosis, Mycobacterium Infections, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium Infections, Atypical, Thalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Aaron Diamond AIDS Research CenterUniversity, hospital or other
- 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 demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.
Detailed description
Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are followed for 28 days. Patients are stratified according to HIV status and stage of HIV infection.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE:
- HIV-positive patients must have CD4 count < 500 cells/mm3 and be on antiretroviral therapy.
- One of the following manifestations:
- Temperature over 38 C on at least two occasions in the week prior to study entry.
- Recent weight loss of more than 5 kilograms.
Key exclusion criteria (5 listed)
- Neuropathy or other disorders with risk of neuropathy.
- Antiretroviral 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 |
|---|---|---|
| Thalidomide | 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thalidomide in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Aaron Diamond AIDS Research Center at 2 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 10 inclusion and 5 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 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.