Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Summary
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure. ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
Timeline
- Start
- 2008-08
- Primary completion
- 2010-06
- Completion
- 2011-06
Outcome
Missed primary endpoint
paper There were no differences between the two groups for the primary efficacy endpoints in those participants who stopped cART at week 28. PMID 24525316 ↗
paper The proportion of participants resuming cART before end of study and change in CD4 counts during the treatment interruption showed no benefit of vaccination. PMID 24525316 ↗
release “As announced October 1, the Vacc-4x phase IIB study did not meet its two primary endpoints” bionorholding.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vacc-4x | Peptide | 1.2 mg | Other |