- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001763
Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Allergy and Infectious Diseases (NIAID)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Documented HIV infection (ELISA and Western blot positive).
18 years or older.
Clinically stable enough to travel to NIH and meet protocol schedule requirements.
Negative urine or serum pregnancy test within 14 days prior to study entry (for women of childbearing potential).
Patients should be receiving a combination of FDA approved antiretroviral drugs or expanded access antiretroviral therapy for at least two weeks prior to study entry. The exception would be that, in the opinion of the primary treating physician, this therapy would not likely provide benefit.
Greater than or equal to 1 positive blood culture or 1 positive culture from a normally sterile site (e.g. lymph node, bone marrow, etc.) for MAC within 6 weeks of study. The initial screening blood culture at the NIH must be positive.
The following lab values must be present at study entry:
Transaminases, alkaline phosphatase, total bilirubin less than or equal to 5x upper limit of normal range.
Serum creatinine less than or equal to 2.0 mg/ml.
Proteinuria less than or equal to positive 1.
Normal PT/PTT.
Granulocyte count greater than or equal to 750/cubic millimeter.
Hemoglobin greater than or equal to 8 gm/dL and platelet count greater than or equal to 75,000.
Fasting Blood glucose 1.25x upper normal limit (126 g/dl). (In persons with no history of diabetes.)
No malignancy other than Kaposi sarcoma. Patients with Kaposi sarcoma are eligible, but must not have received systemic therapy for KS.
No current life threatening AIDS related opportunistic infection other than disseminated MAC.
No evidence of active substance abuse according to the standard 8th floor clinic substance abuse assessment, which allows enrollment at the discretion of the principal investigator.
No patients exhibiting psychiatric disturbance or illness, which in the assessment of the protocol team may affect patient safety or compliance.
No significant cardiac, gastrointestinal, pulmonary, autoimmune, renal, or CNS disease which could interfere with patient safety.
No hypertension requiring anti-hypertensive therapy.
No pregnant or lactating patients, or any patient with an inability or unwillingness to use effective contraception.
Willingness to comply with current NIH Clinical Center guidelines concerning appropriate notification by an individual of current or ongoing sexual partners and/or needle-sharing partners regarding his or her HIV seropositivity and the risk of transmission of HIV infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- Bermudez LE, Martinelli J, Petrofsky M, Kolonoski P, Young LS. Recombinant granulocyte-macrophage colony-stimulating factor enhances the effects of antibiotics against Mycobacterium avium complex infection in the beige mouse model. J Infect Dis. 1994 Mar;169(3):575-80. doi: 10.1093/infdis/169.3.575.
- Chaisson RE, Benson CA, Dube MP, Heifets LB, Korvick JA, Elkin S, Smith T, Craft JC, Sattler FR. Clarithromycin therapy for bacteremic Mycobacterium avium complex disease. A randomized, double-blind, dose-ranging study in patients with AIDS. AIDS Clinical Trials Group Protocol 157 Study Team. Ann Intern Med. 1994 Dec 15;121(12):905-11. doi: 10.7326/0003-4819-121-12-199412150-00001.
- Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. doi: 10.1097/00002030-199703110-00008.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Slow Virus Diseases
- Mycobacterium Infections, Nontuberculous
- HIV Infections
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Mycobacterium avium-intracellulare Infection
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Adjuvants, Immunologic
- Interleukin-12
Other Study ID Numbers
- 980091
- 98-I-0091
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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