check_circleStudy Completed

HIV infections

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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
56
Trial Dates
December 2002 - March 2005
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Interleukin-2 SA (BAY50-4798)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
London, SW10 9NH, United Kingdom
Completed
Birmingham, 35294-2050, United States
Completed
Sacramento, 95814, United States
Completed
Los Angeles, 90095-7156, United States
Completed
Chicago, 60612-3820, United States
Completed
San Francisco, 94115, United States
Completed
Bethesda, 20892, United States
Completed
CRETEIL, 94000, France
Completed
Chicago, 60611-2908, United States
Completed
Cleveland, 44106-3808, United States
Completed
Palo Alto, 94304-1207, United States
Withdrawn
PARIS, 75634, France
Withdrawn
Tulsa, 74127, United States
Withdrawn
Dallas, 75216-7167, United States

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2