CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Vacc-4xbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01712256
NCT01712256Phase 2Completed

Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Re-boosting Study With Vacc-4x in Subjects Infected With HIV-1 Who Have Maintained an Adequate Response to ART

Bionor Immuno AS·interventional·Posted Oct 23, 2012·Updated Mar 6, 2017

In Brief

A Phase 2 clinical trial evaluating Vacc-4x for HIV-1 Infection. Completed, enrolled 33 participants across 10 sites in 5 countries.

Detailed Summary

During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV. All patients participating in this trial have previously received the vacc-4x vaccine in order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The primary objective of this study is to evaluate if a re-boost with Vacc-4x could further reduce the amount of HIV-1 virus and increase the immune response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesGermany, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 23, 2012
Enrollment StartDec 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.7 years ago

Interventions

Vacc-4xbiological

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