- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00001763
Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- National Institute of Allergy and Infectious Diseases (NIAID)
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- RNA-virusinfektioner
- Virussygdomme
- Blodbårne infektioner
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Sygdomme i immunsystemet
- Sygdomsegenskaber
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-positive bakterielle infektioner
- Actinomycetales infektioner
- Langsomme virussygdomme
- Mycobacterium-infektioner, ikke-tuberkuløse
- HIV-infektioner
- Infektioner
- Overførbare sygdomme
- Mycobacterium infektioner
- Erhvervet immundefektsyndrom
- Immunologiske mangelsyndromer
- Mycobacterium avium-intracellulare infektion
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Immunologiske faktorer
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Adjuvanser, immunologiske
- Interleukin-12
Andre undersøgelses-id-numre
- 980091
- 98-I-0091
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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