Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00111397 · ClinicalTrials.gov registry record · Phase 1
Adjuvant Cytokine Therapy to Treat Pulmonary Mycobacterium Avium Complex Infection
A Phase 1 study of Mycobacterium Avium-Intracellulare Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT00111397: Completed Phase 1 study of Mycobacterium Avium-Intracellulare Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00111397 is a Phase 1 study of Mycobacterium Avium-Intracellulare Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2 participants, below the 389-participant average among 6 other Mycobacterium Avium-Intracellulare Infection trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00111397, a Phase 1 study of Mycobacterium Avium-Intracellulare Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
Mycobacterium avium complex (MAC) are ubiquitous organisms that cause isolated pulmonary disease in otherwise healthy patients with yet undefined susceptibilities. Patients typically present with a history of chronic cough, eventually progressing to hemoptysis, fever, and hypoxia. With half or more of all patients failing standard three-drug therapy, this is an insidious disease with a poor prognosis. Under the natural history protocol of nontuberculous mycobacterial infection (NTM; #01-I-0202), 46 patients with diagnosed pulmonary MAC disease are being studied. Numerous studies have suggested that a dysregulation in cytokine production may make these patients susceptible to mycobacterial infection. Cytokines are particularly important in the activaction of macrophages, which help to clear mycobacterial infection. Interferon gamma 1b (Actimmune) and GM-CSF (Leukine) are two cytokine therapies that have been approved in the treatment of chronic granulomatous disease and post-transplantation hematopoietic reconstitution, respectively. A number of in vitro studies suggest that either or both of these therapies may help to clear MAC infection. Given the poor outcomes of therapy and the persistent, debilitating nature of the disease, new therapies are desperately needed, and many are being tried without benefit of scientific foundation. Currently, there are no prospective trials that show any effect of these drugs in the lung delivered subcutaneously. This protocol proposes to perform a pilot study to evaluate the effects, if any, of these macrophage stimulating cytokines in the context of ongoing pulmonary MAC infection. Aims: To determine the local and systemic effect, if any, of adjuvant IFN gamma and GM-CSF in pulmonary MAC patients. Methods: Fifteen patients will be randomized into three treatment groups of five patients each. The first group will receive a standard drug regimen, based on the 1997 ATS guidelines. The second and third groups, in addition to recei
Conditions Studied
Interventions
- PROCEDURE Cytokine therapy
- DRUG Interferon Gamma, GM-CSF
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2005-05-13 |
| Est. Completion | 2010-08-04 |
| Phase | Phase 1 |
What the finished NCT00111397 record still lists
NCT00111397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 389-participant average among 6 other Mycobacterium Avium-Intracellulare Infection trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Mycobacterium Avium-Intracellulare Infection appearing as the primary indexed condition, and to 2 interventions - of which Cytokine therapy is the first listed.
NCT00111397 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00111397 about?
NCT00111397 is a clinical study titled "Adjuvant Cytokine Therapy to Treat Pulmonary Mycobacterium Avium Complex Infection". Mycobacterium avium complex (MAC) are ubiquitous organisms that cause isolated pulmonary disease in otherwise healthy patients with yet undefined susceptibilities. Patients typically present with a history of chronic cough, eventually progressing to hemoptysis, fever, and hypoxia. With half or more ...
What is the current status of trial NCT00111397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2005-05-13. Estimated completion is 2010-08-04.
What conditions does trial NCT00111397 study?
This clinical trial studies the following conditions: Mycobacterium Avium-Intracellulare Infection.
What interventions are being tested in trial NCT00111397?
The interventions under investigation include: Cytokine therapy (PROCEDURE), Interferon Gamma, GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00111397?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00111397 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mycobacterium Avium-Intracellulare Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
COMPLETED · Phase 1
-
A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
COMPLETED · NA
-
A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
COMPLETED
-
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study
COMPLETED · NA
-
The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
COMPLETED · Phase 3
-
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
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI