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Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
NCT00001763 · View on ClinicalTrials.gov ↗
Study Summary
Disseminated infection with Mycobacteria avium complex (MAC) is one of the most common systemic bacterial infections in advanced stages of the acquired immunodeficiency syndrome (AIDS). Current therapy for disseminated MAC infection in HIV patients consists of multidrug chemotherapy regimens are often accompanied by toxicities, and many patients become intolerant of one or more agents. Macrolides are the essential component of successful therapy, yet macrolide resistant strains are being recognized with increasing frequency. Thus, there is an interest in identifying additional therapeutic interventions for disseminated MAC in HIV-infected patients. Interleukin-12 (IL-12) is a central, regulatory cytokine in cell-mediated immunity. IL-12 enhances the cytolytic activity of cytotoxic T and NK cells, and induces interferon-gamma (IFN gamma) production from T and NK cells. This open-label Phase I study is designed to evaluate the safety and immunologic/microbiologic effects of interleukin-12 administration in HIV-infected patients with concomitant disseminated Mycobacterium avium (MAC) infection. Fifteen patients with documented disseminated MAC will be randomized to receive double-blinded placebo or escalating doses of IL-12 in addition to anti-MAC chemotherapy and standard anti-retroviral therapy for six weeks. IL-12 will be administered subcutaneously, with escalating doses every month over the dose range of 30 ng/kg, 100 ng/kg, and 300 ng/kg, or until an individual maximum tolerated dose (IMTD) is reached. Should a patient receive 2 consecutive blood cultures negative for MAC during the course of the study at a lower dose, then he/she will not be further dose escalated. Those patients receiving placebo after 6 weeks will be crossed over to receive the full treatment course of IL-12. Each new dose or dose escalation will take place on an inpatient basis. Once a patient is clinically stable at a dose, the patient will be maintained at that dose as an outpatient for the
Conditions Studied
Interventions
- DRUG Interleukin-12
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1998-04 |
| Est. Completion | 2000-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001763
The ClinicalTrials.gov registry entry for NCT00001763 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Acquired Immunodeficiency Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Interleukin-12 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00001763 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00001763 about?
NCT00001763 is a clinical study titled "Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection". Disseminated infection with Mycobacteria avium complex (MAC) is one of the most common systemic bacterial infections in advanced stages of the acquired immunodeficiency syndrome (AIDS). Current therapy for disseminated MAC infection in HIV patients consists of multidrug chemotherapy regimens are oft...
What is the current status of trial NCT00001763?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 1998-04. Estimated completion is 2000-03.
What conditions does trial NCT00001763 study?
This clinical trial studies the following conditions: Acquired Immunodeficiency Syndrome, Mycobacterium Avium-Intracellulare Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00001763?
The interventions under investigation include: Interleukin-12 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00001763?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00001763 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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