Phase 2
N=33
Re-boosting of HIV-1 Infected Subjects With Vacc-4x
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT01712256 ↗Enrolled (actual)
33
Serious AEs
6.1%
Results posted
Mar 2017
Primary outcome: Primary: Vacc-4x Effect on Viral Load Set-point — 38455.0; 40088.8; 45253.9; 47336.8 Copies/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vacc-4x (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bionor Immuno AS
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vacc-4x Effect on Viral Load Set-point |
38455.0; 40088.8; 45253.9; 47336.8 | — |
| SECONDARY Vacc-4x Effect on Immune Response Measured as CD4 Count |
782.21; 795.74; 764.8; 778.1; 791.1; 805.6 | — |
| SECONDARY Vacc-4x Effect on Immune Response Measured as CD8 Count |
979.43; 972.19; 988.7; 971.4; 926.3; 919.0 | — |
| SECONDARY Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration |
10; 9; 20; 19 | — |
| SECONDARY Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema |
19; 17; 19; 18 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
31; 19; 2; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) in the CT-BI Vacc-4x 2007/1 study. (No re-start of ART is required).
- Documented pre-study CD4 cell count ≥400x106/L.
- Documented pre-study viral load 1.5 x upper limit of normal (ULN), and AST, ALT and alkaline phosphatase (ALP) values >2.5 x ULN.
- Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.
- Pregnant or breastfeeding women.
- Women of childbearing potential not using reliable and adequate contraceptive methods (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence; sterile) during the 5 weeks re-boosting period including the DTH and for 2 weeks after the DTH test, or sexually active male subjects with partners of child bearing potential unwilling to practice effective contraception during the 5 weeks re-boosting period including the DTH and for 12 weeks after the DTH-test.
- Current participation in other clinical therapeutic studies.
- Incapability of compliance to treatment protocol, in the opinion of the Investigator.
Data sourced from ClinicalTrials.gov (NCT01712256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.