Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 9, 2002

Keywords

ClinConnect 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 i...

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Eligibility criteria

• • 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.