HIV I Infection
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGVacc-4x
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
DRUGSterile water
Sterile water is used in place of Vacc-4x and in place of Leukine
Sponsors
Bionor Immuno AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-55 * HIV positive at least one year * Clinically stable on ART for at least six months * Documented viral load less than 50 copies/mL for the last six months * Documented prestudy CD4 cell count equal or more than 400x10exp6/L * Nadir CD4 cell count equal or more than 200x10exp6/L * Signed informed consent
Exclusion criteria
* Reported pre-study AIDS-defining illness within the previous year * Malignant disease * On chronic treatment with immuno-suppressive therapy * Unacceptable values of hematology and clinical chemistry parameters * Current chronic infection such as HCV and HBV or active tuberculosis * Pregnant or breastfeeding women * Not using safe contraceptive methods * Participation in other clinical trial * Incapability of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | From Week 28 to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Up to week 52 | Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004. |
| Immunogenicity | Week 1, week 18 and week 52 | Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema |
| Effect of Vacc-4x on CD8 Counts | Weeks 6,18,24,28,32,36,40,44,48,52. | CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52 |
| Time to Restart of ART for Vacc-4x Subjects Versus Placebo | Between Week 28 to Week 52 | Kaplan-Meier Estimate of Time to restart ART (from time coming off ART) |
| Effects on Vacc-4x on HIV-1 RNA | Weeks 24,28,32,36,40,44,48,52. | — |
Countries
Germany, Italy, Spain, United Kingdom, United States
Participant flow
Recruitment details
The first subject was screened on 29 July 2008 and the first immunization was given on 22 August 2008. The last subject completed the study (to Week 52) on 22 June 2010. The last long-term follow-up visit was 07 June 2011.
Pre-assignment details
137 study participants were enrolled. One participant withdrew prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18. | 92 |
| Placebo Injections (Group II) While on ART Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18. | 43 |
| Total | 135 |
Baseline characteristics
| Characteristic | Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Total | Placebo Injections (Group II) While on ART |
|---|---|---|---|
| Age, Customized Age, Categorial <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age, Categorial >=55 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age, Categorial Between 15 and 55 | 92 Participants | 135 Participants | 43 Participants |
| CD4 nadir | 300 10^6 cells/L | 298 10^6 cells/L | 285 10^6 cells/L |
| Gender Female | 14 Participants | 19 Participants | 5 Participants |
| Gender Male | 78 Participants | 116 Participants | 38 Participants |
| Height | 175 cm | 175 cm | 175 cm |
| Pre-ART CD4 | 339 10^6 cells/L | 357 10^6 cells/L | 370 10^6 cells/L |
| Pre-ART HIV-1 viral load | 94810 copies/mL | 75398 copies/mL | 25630 copies/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 88 Participants | 125 Participants | 37 Participants |
| Time since HIV diagnosis (days) | 3861 days | 4309 days | 4480 days |
| Total time on ART | 95.5 months | 108 months | 112 months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 91 / 93 | 40 / 42 |
| serious Total, serious adverse events | 4 / 93 | 3 / 42 |
Outcome results
Primary
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Time frame: From Week 28 to Week 52
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects coming off ART at Week 28 | 88 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects resuming ART between week 28 and 52 | 30 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects not qualifying for ART interruption | 0 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects restarting ART at Week 52/termination | 12 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Number of subjects attending Week 28 visit | 88 participants |
| Placebo Injections (Group II) While on ART. | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects restarting ART at Week 52/termination | 7 participants |
| Placebo Injections (Group II) While on ART. | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Number of subjects attending Week 28 visit | 40 participants |
| Placebo Injections (Group II) While on ART. | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects coming off ART at Week 28 | 38 participants |
| Placebo Injections (Group II) While on ART. | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects not qualifying for ART interruption | 1 participants |
| Placebo Injections (Group II) While on ART. | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | Subjects resuming ART between week 28 and 52 | 11 participants |
Secondary
Effect of Vacc-4x on CD8 Counts
CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52
Time frame: Weeks 6,18,24,28,32,36,40,44,48,52.
Population: Subject who stopped ART at week 28 and remained off ART until week 52
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 6 (Vacc-4x n=54;placebo n=25) | 786.0 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 18 (Vacc-4x n=56; placebo n=25) | 853.5 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 24 (Vacc-4x n=56; placebo n=25) | 804.0 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 28 (Vacc-4x n=56; placebo n=25) | 820.5 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 32 (Vacc-4x n=56; placebo n=25) | 962.0 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 36 (Vacc-4x n=56; placebo n=25) | 1385.5 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 40 (Vacc-4x n=54; placebo n=25) | 1252.5 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 44 (Vacc-4x n=56; placebo n=25) | 1156.0 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 48 (Vacc-4x n=55; placebo n=24) | 1118.0 cells/µL |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effect of Vacc-4x on CD8 Counts | week 52 (completers) (Vacc-4x n=56;placebo n=25) | 1064.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 44 (Vacc-4x n=56; placebo n=25) | 1106.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 6 (Vacc-4x n=54;placebo n=25) | 865.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 36 (Vacc-4x n=56; placebo n=25) | 1416.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 18 (Vacc-4x n=56; placebo n=25) | 897.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 52 (completers) (Vacc-4x n=56;placebo n=25) | 1047.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 24 (Vacc-4x n=56; placebo n=25) | 771.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 40 (Vacc-4x n=54; placebo n=25) | 1253.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 28 (Vacc-4x n=56; placebo n=25) | 879.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 48 (Vacc-4x n=55; placebo n=24) | 1217.0 cells/µL |
| Placebo Injections (Group II) While on ART. | Effect of Vacc-4x on CD8 Counts | week 32 (Vacc-4x n=56; placebo n=25) | 1161.0 cells/µL |
Secondary
Effects on Vacc-4x on HIV-1 RNA
Time frame: Weeks 24,28,32,36,40,44,48,52.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 24 (Vacc-4x n=90; placebo n=41) | 629.6 copies/mL | Standard Deviation 5807.26 |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 28 (Vacc-4x n=89; placebo n=40) | 1351.4 copies/mL | Standard Deviation 5710.99 |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 32 (Vacc-4x n=88; placebo n=38) | 192115.0 copies/mL | Standard Deviation 361003.4 |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 36 (Vacc-4x n=81; placebo n=35) | 89134.8 copies/mL | Standard Deviation 165945.62 |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 40 (Vacc-4x n=71; placebo n=32) | 72705.0 copies/mL | Standard Deviation 143582.93 |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 44 (Vacc-4x n=63; placebo n=27) | 44969.7 copies/mL | Standard Deviation 65798.22 |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 48 (Vacc-4x n=59; placebo n=25) | 48848.2 copies/mL | Standard Deviation 90232.17 |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Effects on Vacc-4x on HIV-1 RNA | week 52 (Vacc-4x n=56; placebo n=24) | 35219.6 copies/mL | Standard Deviation 42181.85 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 52 (Vacc-4x n=56; placebo n=24) | 67684.0 copies/mL | Standard Deviation 67869.61 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 24 (Vacc-4x n=90; placebo n=41) | 9.2 copies/mL | Standard Deviation 22.85 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 40 (Vacc-4x n=71; placebo n=32) | 76127.8 copies/mL | Standard Deviation 81891.91 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 28 (Vacc-4x n=89; placebo n=40) | 1628.5 copies/mL | Standard Deviation 10131.81 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 48 (Vacc-4x n=59; placebo n=25) | 77219.4 copies/mL | Standard Deviation 70851.98 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 32 (Vacc-4x n=88; placebo n=38) | 205605.2 copies/mL | Standard Deviation 383020.31 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 44 (Vacc-4x n=63; placebo n=27) | 66203.3 copies/mL | Standard Deviation 72099.23 |
| Placebo Injections (Group II) While on ART. | Effects on Vacc-4x on HIV-1 RNA | week 36 (Vacc-4x n=81; placebo n=35) | 89211.9 copies/mL | Standard Deviation 97983.28 |
Secondary
Immunogenicity
Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema
Time frame: Week 1, week 18 and week 52
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Erythema week 18 (Vacc-4x n=88; placebo n=41) | 40 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Erythema week 52 (Vacc-4x n=78;placebo n=36) | 34 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Erythema week 1 (Vacc-4x n=92;placebo n=43) | 3 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Induration week 1 (Vacc-4x n=92; placebo n=43 | 3 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Induration week 18 (Vacc-4x n=88; placebo n=41) | 27 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Induration week 52 (Vacc-4x n=78; placebo n=36) | 26 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Induration week 52(LOCF) Vacc-4x n=92;placebo n=43 | 30 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunogenicity | Erythema week 52 (LOCF) Vacc-4x n=92;placebo n=43 | 40 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Erythema week 52 (LOCF) Vacc-4x n=92;placebo n=43 | 0 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Erythema week 18 (Vacc-4x n=88; placebo n=41) | 0 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Induration week 18 (Vacc-4x n=88; placebo n=41) | 0 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Erythema week 52 (Vacc-4x n=78;placebo n=36) | 0 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Induration week 52(LOCF) Vacc-4x n=92;placebo n=43 | 0 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Erythema week 1 (Vacc-4x n=92;placebo n=43) | 1 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Induration week 52 (Vacc-4x n=78; placebo n=36) | 0 participants |
| Placebo Injections (Group II) While on ART. | Immunogenicity | Induration week 1 (Vacc-4x n=92; placebo n=43 | 1 participants |
Secondary
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.
Time frame: Up to week 52
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Life threatening | 1 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Severe | 4 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Mild | 27 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Life threatening | 0 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE up to week 52/early termination | 81 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any TESAE up to week 52/early termination | 4 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Severe | 9 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any related TESAE up to week 52/early termination | 1 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Mild | 40 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any TEAE leading to treatment discontinuation | 2 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Moderate | 54 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Treatment-related TEAE leading to discontinuation | 2 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Moderate | 37 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Deaths | 0 participants |
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any TEAE up to week 52/early termination | 91 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Deaths | 1 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any TEAE up to week 52/early termination | 40 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Mild | 13 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Moderate | 21 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Severe | 6 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | TEAE - Life threatening | 0 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE up to week 52/early termination | 24 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Mild | 19 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Moderate | 5 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Severe | 0 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Related TEAE - Life threatening | 0 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any TESAE up to week 52/early termination | 3 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any related TESAE up to week 52/early termination | 0 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Any TEAE leading to treatment discontinuation | 0 participants |
| Placebo Injections (Group II) While on ART. | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | Treatment-related TEAE leading to discontinuation | 0 participants |
Secondary
Time to Restart of ART for Vacc-4x Subjects Versus Placebo
Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)
Time frame: Between Week 28 to Week 52
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Time to Restart of ART for Vacc-4x Subjects Versus Placebo | 141.8 days | Standard Deviation 47.4 |
| Placebo Injections (Group II) While on ART. | Time to Restart of ART for Vacc-4x Subjects Versus Placebo | 133.5 days | Standard Deviation 57.27 |