Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00059462
• Date of registration: 25/04/2003
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
• Scientific 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.
• Date of first enrolment: December 2002
• Target sample size: 56
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00059462
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

France, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: HAART

Drug: Interleukin-2 SA

Secondary ID(s)

10630

Source(s) of Monetary Support

Please refer to primary and secondary sponsors