Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Interleukin-2 SA (Drug); HAART (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in
HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell
count.
Clinical Details
Official title: Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Documented HIV infection (positive enzyme linked immuno assay (EIA) confirmed by
Western Blot).
- Age greater than or equal to 18 years.
- Plasma HIV viral load less than 10,000 copies/ml (by bDNA assay or less than 14,000
copies/ml by RT-PCR) on at least 2 occasions within 8 weeks prior to study entry with
no more than a 0. 5 log increase between the most recent and the earlier viral load
measurements.
- CD4 + T-cell count greater than or equal to 200/mm(3) on at least 2 occasions within
8 weeks of study entry.
- On a stable HAART regimen for greater than or equal to 8 weeks.
- Karnofsky Score greater than or equal to 80.
- Written informed consent. Exclusion Criteria:
- Prior treatment with IL-2 or an IL-2 analogue.
- Pregnancy or breastfeeding. - Use of any known immunomodulators, cytokines, growth
factors or systemic corticosteroids (e. g. prednisone greater than or equal to 15
mg/day or equivalent) within 4 weeks prior to study enrollment.
- History of an AIDS defining illness by the Centers for Disease Control (CDC)
definition within 8 weeks prior to study entry.
- Acute bacterial or viral infection within 4 weeks prior to enrollment.
- Received an immunization within 4 weeks prior to enrollment.
- History of autoimmune disease including psoriasis, inflammatory bowel disease.
- Medical history of transplantation (solid organ or bone marrow).
- Received an investigational drug in the past 30 days other than Food and Drug
Administration (FDA) sanctioned treatment IND antiretroviral agents.
- Renal insufficiency with a serum creatinine level greater than 1. 5 times the upper
limit of normal.
- Bone marrow suppression as defined by one or more of the following: granulocyte count
less than 1,000 cells/µL; hemoglobin less than 9. 0g (females) or less than 9. 5g
(males); or platelet count less than 75,000 cells/µL.
- Evidence of hepatic disease indicated by one or more of the following: SGOT (AST)
and/or SGPT (ALT) greater than 5 times the upper limit of normal. Bilirubin greater
than 2 times the upper limit of normal (except for patients with known Gilbert's
syndrome or those receiving indinavir who may be enrolled if the serum bilirubin is
less than or equal to 5 times the upper limit of normal).
- Active cardiac disease (coronary artery disease, congestive heart failure or
cardiomyopathy) requiring treatment with any of the following medications:
antiarrhythmic agents including digitalis, anti-anginal drugs including topical or
systemic nitrates, calcium channel blockers, and beta blockers, and afterload
reducers including ACE inhibitors. Patients requiring any of these medications solely
for the treatment of hypertension remain eligible for the study.
- Presence of significant cardiac insufficiency (greater than or equal to New York
Heart Association Grade 2).
- Diagnosis of an active malignancy requiring treatment with systemic cytotoxic
chemotherapy.
- Active alcohol or substance abuse which, in the opinion of the investigator, will
seriously compromise the subject's ability to adhere with the demands of the study.
- Any central nervous system (CNS) disease that requires active treatment with
anticonvulsants.
- Use of an antimetabolite such as hydroxyurea within 4 weeks prior to study entry.
- Known co-infection with Hepatitis B or C virus unless serum transaminases are less
than or equal to 2 times the upper limit of normal on at least two occasions within 8
weeks prior to study entry.
- Known CD4 Nadir less than 50 cells/mm(3).
Locations and Contacts
Creteil 94010, France
Birmingham, Alabama 35294, United States
Davis, California 95616, United States
Los Angeles, California 90095, United States
Palo Alto, California 94304-1207, United States
San Francisco, California 94115, United States
London, Greater London SW10 9NH, United Kingdom
Chicago, Illinois 60611-2908, United States
Chicago, Illinois 60612, United States
Bethesda, Maryland 20892, United States
Cleveland, Ohio 44106-2602, United States
Additional Information
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Starting date: December 2002
Last updated: December 18, 2014
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