drugset / Trial / NCT01130376

Novel Interventions in HIV-1 Infection

NCT01130376

RandomizedParallel-groupOpen-labelTreatment

Summary

For several years there has been interest in why some people with HIV-1 progress more slowly to disease and have longer survival without Highly Active Antiretroviral Therapy (HAART) than others. The investigators and others have identified a few HIV positive individuals who can control their viral load for many years without HAART, these rare individuals do not lose their HIV-1-specific cellular immune responses, which are very important for controlling viral load. This group is referred to as long-term non-progressors (LTNP). Unlike LTNP the majority of HIV-1 infected individuals are chronic progressors (CP) who do not make effective HIV-1-specific cellular immune responses, even when on HAART. We propose to use a novel DNA vaccine boosted with immune based therapy (cytokines and hormones) to try to regenerate the missing HIV-1-specific cellular immune responses to make chronically infected HIV-1+ persons more like LTNP. By injecting this novel DNA vaccine and immune based therapy into the people who are already infected with HIV-1, the immune system may be stimulated to mount a greater immune response not only to the vaccines but also to real HIV-1 particles and HIV-1-infected cells.

Timeline

Start
2009-09
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GTU-MultiHIV B clade vaccine Vaccine 1 mg/ml
Subject Somatropin Protein / enzyme biologic 4 mg Subcutaneous
Subject aldesleukin Protein / enzyme biologic 5e+06 iu Subcutaneous
Subject sargramostim Protein / enzyme biologic 150 ug Subcutaneous