Trial Outcomes & Findings for Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects (NCT NCT01610427)
NCT ID: NCT01610427
Last Updated: 2020-04-24
Results Overview
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h \["none" resting time not included\]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10\^P/(1 + 10\^P)\*100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + a\*a\*TP\*TP + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting the intercept i.e. expected mean value of Prediction when "TP" and "RT" = 0. The optimum of this Design of Experiment is presented in outcome 4.
COMPLETED
NA
22 participants
At Day 15 (sample collection visit)
2020-04-24
Participant Flow
Of 31 subjects registered in the study, 9 subjects were screen failures and 22 subjects were enrolled in the study.
Participant milestones
| Measure |
HIV-1 Group
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
Baseline characteristics by cohort
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African heritage / African American
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1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian - East Asian heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White - Caucasian / European heritage
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20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h \["none" resting time not included\]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10\^P/(1 + 10\^P)\*100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + a\*a\*TP\*TP + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting the intercept i.e. expected mean value of Prediction when "TP" and "RT" = 0. The optimum of this Design of Experiment is presented in outcome 4.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (LOGIT Transformed) in CMI Samples Post-overnight Incubation Time Before Intracellular Cytokine Staining (ICS): "Intercept" Parameter Estimate of the Prediction Model - Condition "None" Resting Time Not Included
|
0.6490 Unitless assessment of prediction
Standard Error 0.06989
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h \["none" resting time not included\]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 \^ P / (1 + 10 \^ P) \* 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + a\*a\*TP\*TP + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting "TP" and "RT" estimates expressed as log(hours). The optimum of this Design of Experiment (DOE) is presented in outcome 4.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition "None" Resting Time Not Included
TP
|
0.1724 Log(hours)
Standard Error 0.1152
|
|
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition "None" Resting Time Not Included
RT
|
0.9578 Log(hours)
Standard Error 0.1342
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h \["none" resting time not included\]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 \^ P / (1 + 10 \^ P) \* 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + a\*a\*TP\*TP + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting TP\*RT, TP\*TP and RT\*RT estimates expressed as log(hours\^2). The optimum of this DOE is presented in outcome 4.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT, TP*TP and RT*RT Parameter Estimates of the Prediction Model - Condition "None" Resting Time Not Included
TP*RT
|
0.1120 Log(hours^2)
Standard Error 0.05041
|
|
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT, TP*TP and RT*RT Parameter Estimates of the Prediction Model - Condition "None" Resting Time Not Included
TP*TP
|
-0.2934 Log(hours^2)
Standard Error 0.06426
|
|
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT, TP*TP and RT*RT Parameter Estimates of the Prediction Model - Condition "None" Resting Time Not Included
RT*RT
|
-0.9364 Log(hours^2)
Standard Error 0.08133
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=2h, 6h or 18h \["none" resting time not included\]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 \^ P / (1 + 10 \^ P) \* 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + a\*a\*TP\*TP + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the "TP" and the "RT" where the prediction has to be done. The optimum predicted mean cell viability of this Design of Experiment is presented in this outcome and expressed as percentage.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Optimum Mean Cell Viability Estimate by the Prediction Model - Condition "None" Resting Time Not Included
|
89.69 Percentage of viable lymphocytes
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 \^ P / (1 + 10 \^ P) \* 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting the intercept i.e. expected mean value of Prediction when "TP" and "RT" = 0. The optimum of this Design of Experiment is presented in outcome 8.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: "Intercept" Parameter Estimate of the Prediction Model - Condition "None" Resting Time Included
|
0.8145 Unitless assessment of prediction
Standard Error 0.03753
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 \^ P / (1 + 10 \^ P) \* 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting "TP" and "RT" estimates expressed as log(hours). The optimum of this Design of Experiment (DOE) is presented in outcome 8.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition "None" Resting Time Included
TP
|
-0.01853 Log(hours)
Standard Error 0.001194
|
|
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition "None" Resting Time Included
RT
|
0.04616 Log(hours)
Standard Error 0.005642
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 \^ P / (1 + 10 \^ P) \* 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. This outcome is presenting TP\*RT and RT\*RT estimates expressed as log(hours\^2). The optimum of this DOE is presented in outcome 8.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT and RT*RT Parameter Estimates of the Prediction Model - Condition "None" Resting Time Included
TP*RT
|
0.000588 Log(hours^2)
Standard Error 0.000121
|
|
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT and RT*RT Parameter Estimates of the Prediction Model - Condition "None" Resting Time Included
RT*RT
|
-0.00367 Log(hours^2)
Standard Error 0.000284
|
PRIMARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The objective was to model lymphocyte viability according to "time-to-process" (TP=2h, 7h or 24h) and "resting time" (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 \^ P / (1 + 10 \^ P) \* 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a\*TP + b\*RT + a\*b\*TP\*RT + + b\*b\*RT\*RT. Where "intercept", "TP", "RT", "TP\*RT", "TP \*TP", "RT\*RT" are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And "a" and "b" are parameters (hour) corresponding respectively to the "TP" and the "RT" where the prediction has to be done. The optimum predicted mean cell viability of this Design of Experiment is presented in this outcome and expressed as percentage.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Optimum Mean Cell Viability Estimates by the Prediction Model -Condition "None" Resting Time Included.
|
89.49 Percentage of viable lymphocytes
|
SECONDARY outcome
Timeframe: A Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
The percentage of viable lymphocytes was determined by Forward Scatter/Side Scatter (FSC/SSC) and LIVE/DEAD gating during flow cytometry analysis for each incubation of time-to-time process (TP) = 2h, 7h and 24 h and resting time (RT) = 18h for the comparison of resting time = 18h and classic incubation time versus resting time = 18h and post-6h incubation time.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS
TP=2h; RT=18h; post 6h incubation
|
82.30 Percentage of viable lymphocytes
Interval 79.57 to 84.74
|
|
Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS
TP=2h; RT=18h; classic incubation
|
72.72 Percentage of viable lymphocytes
Interval 69.07 to 76.09
|
|
Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS
TP=7h; RT=18h; post 6h incubation
|
82.49 Percentage of viable lymphocytes
Interval 76.09 to 84.97
|
|
Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS
TP=7h; RT=18h; classic incubation
|
73.65 Percentage of viable lymphocytes
Interval 70.0 to 77.01
|
|
Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS
TP=24h; RT=18h; post 6h incubation
|
72.64 Percentage of viable lymphocytes
Interval 68.83 to 76.15
|
|
Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS
TP=24h; RT=18h; classic incubation
|
64.60 Percentage of viable lymphocytes
Interval 60.41 to 68.58
|
SECONDARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was to be performed on the According to Protocol (ATP) Sample Collection cohort. Data were collected but could not be reported as data were below the detection level.
Data were collected but could not be reported as data were below level of detection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 15 (sample collection visit)Population: The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.
HIV-RT specific responses of CD8+ T cells expressing at least one cytokine, among: Interleukin-2 (IL-2), Interferon-gamma (IFN-g) and Tumor necrosis factor alpha (TNF-a),after stimulation with HIV-1 peptide pools for time-to-process (TP) (2, 7, 24 hours) and resting time (RT) (0,2,6,18 hours) post-overnight ICS and for time-to-process (7 hours) and resting time (18 hours) post 6 hours ICS.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 2h RT 0h post-overnight ICS
|
0.257075 Percentage of CD8+ T cells
Interval 0.165275 to 0.492275
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 2h RT 2h post-overnight ICS
|
0.2757 Percentage of CD8+ T cells
Interval 0.193275 to 0.56075
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 2h RT 6h post-overnight ICS
|
0.3059 Percentage of CD8+ T cells
Interval 0.122015 to 0.465168
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 2h RT 18h post-overnight ICS
|
0.3114 Percentage of CD8+ T cells
Interval 0.1855 to 0.946325
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 7h RT 0h post-overnight ICS
|
0.23485 Percentage of CD8+ T cells
Interval 0.10595 to 0.44535
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 7h RT 2h post-overnight ICS
|
0.2761 Percentage of CD8+ T cells
Interval 0.16446 to 0.54085
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 7h RT 6h post-overnight ICS
|
0.2615 Percentage of CD8+ T cells
Interval 0.141975 to 0.6853
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 7h RT 18h post-overnight ICS
|
0.35455 Percentage of CD8+ T cells
Interval 0.220358 to 0.8207
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 7h RT 18h post 6h ICS
|
0.117 Percentage of CD8+ T cells
Interval 0.0729 to 0.29695
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 24h RT 0h post-overnight ICS
|
0.18731 Percentage of CD8+ T cells
Interval 0.130225 to 0.43595
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 24h RT 2h post-overnight ICS
|
0.29285 Percentage of CD8+ T cells
Interval 0.141575 to 0.644325
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 24h RT 6h post-overnight ICS
|
0.2496 Percentage of CD8+ T cells
Interval 0.1472 to 0.7351
|
|
Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine
TP 24h RT 18h post-overnight ICS
|
0.3663 Percentage of CD8+ T cells
Interval 0.2138 to 1.0977
|
SECONDARY outcome
Timeframe: During the whole study period (From Day 0 to Day 15)Population: The analysis was performed on the Total eligible cohort which included all subjects in the Total cohort (all enrolled subjects) who fulfilled eligibility criteria.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitali-zation or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
HIV-1 Group
n=22 Participants
Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
Adverse Events
HIV-1 Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER