Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Bionor Immuno AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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). 2. Documented pre-study CD4 cell count =400x10e6/L. 3. Documented pre-study viral load =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Reported AIDS-defining illness within the previous year. 2. Malignant disease. 3. On chronic treatment with immune-suppressive therapy. 4. Unacceptable values of the hematologic and clinical chemistry parameters, as judged by the Investigator, including creatinine values >1.5 x upper limit of normal (ULN), and AST, ALT and alkaline phosphatase (ALP) values >2.5 x ULN. 5. Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis. 6. Pregnant or breastfeeding women. 7. 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. 8. Current participation in other clinical therapeutic studies. 9. Incapability of compliance to treatment protocol, in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate if a re-boost with Vacc-4x could a) reduce the viral load set-point, and b) increase the immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1 (EudraCT Number 2007-006302-13).;Secondary Objective: • To evaluate the effect of a re-boost with Vacc-4x on CD4 counts and CD8 counts. • To assesses in vivo immunogenicity of Vacc-4x by evaluation of DTH and to compare the DTH response to the DTH response observed in the initial study; CT-BI Vacc-4x 2007/1 (EudraCT Number 2007-006302-13). • To evaluate the safety and tolerability of re-boosting with Vacc-4x;Primary end point(s): • Viral load set point (mean of VL count week 25 and 29) for subjects discontinuing ART according to protocol and not resuming ART until week 29 compared to: - viral load set point* for subjects not resuming ART before week 52 or later in the CT-BI Vacc-4x 2007/1 study and who entered this study, or if week 52 not reached in the previous study - viral load set point** for subjects resuming ART at the earliest week 40 in the CT-BI Vacc-4x 2007/1 study and who entered this study. * The VL set point was defined as the mean of VL count week 48 and week 52 week in subjects who did not resume ART. **The VL set point was defined as the week 40 VL count for subject resuming ART week 40 or the mean of the last two VL counts prior to ART resumption for subjects resuming ART week 44 or later but before week 52. Comparison will also be made to pre-ART viral load values, if available from the CT-BI Vacc-4x 2007/1 study. • T-cell response will be measured by ELISPOT as well as by T-cell proliferative response assay (Flow Cytometry) and intracellular cytokine staining at Week 1 (before re-boosting), Week 5 (two weeks after re-boosting), Week 17, Week 29 and Week 37. These will be compared to the responses reported in the study CT-BI Vacc-4x 2007/1.;Timepoint(s) of evaluation of this end point: • Viral load set point (mean of VL count week 25 and 29) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • CD4 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study), absolute numbers of CD4 counts, and treatment emergent changes of CD4 counts from mean of Screening and Week 1. • Change (and percent change) in CD4 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37. • CD8 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study), absolute numbers of CD8 counts, and treatment emergent changes of CD8 from mean of Screening and Week 1. • Change (and percent change) in CD8 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37 (End of Study). • DTH (both induration and erythema) at Week 1 and Week 5, in terms of observed areas (mm2 length x height) and also in terms of a positive test, defined as an area = 10mm2 DTH-tests, both areas and number of positive tests registered at Week 1 will be compared with the corresponding values registered at Week 5.;Timepoint(s) of evaluation of this end point: • CD4 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study • Change (and percent change) in CD4 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37. • CD8 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study) • Change (and percent change) in CD8 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37 (End of Study). • DTH (both induration and erythema) at Week 1 and Week 5. | — |
Countries
Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactVidar Wendel-Hansen
Bionor Pharma AS
Outcome results
None listed