Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
HIV-1 Infection
Interventions
DRUG

Lenalidomide

In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

DRUG

Lenalidomide placebo

Capsules are identical to the active Lenalidomide capsules used.

DRUG

Vacc-4X

Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

DRUG

rhuGM-CSF

Granulocyte macrophage colony stimulating factor as a local adjuvant

Trial Locations (4)

12157

EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125, Berlin

13353

Charite Campus, Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Infektiologie Station 59 (Suedring 11) Augustenburger Platz 1, Berlin

20246

University Medical Center Hamburg-Eppendorf, Hamburg

50937

Klinik I für Innere Medizin Klinikum Der Universität zu Köln, Cologne

Sponsors

Collaborators (1)

All Listed Sponsors
lead

Bionor Immuno AS

INDUSTRY

collaborator

Celgene Corporation

INDUSTRY