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Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02440789
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : December 30, 2019
Last Update Posted : August 3, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Intervention Drug: Sirolimus
Enrollment 32
Recruitment Details Participants were recruited at 10 Clinical Research Sites (CRSs) in the United States between December 2015 and March 2017.
Pre-assignment Details  
Arm/Group Title Sirolimus
Hide Arm/Group Description

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Period Title: Overall Study
Started 32
Initiated Sirolimus [1] 30
Completed 20 Weeks of Sirolimus [2] 16
Completed 28
Not Completed 4
Reason Not Completed
Withdrawal by Subject             3
Not willing to adhere to reqs             1
[1]
2 participants withdrew consent prior to initiating Sirolimus
[2]
14 participants completed less than 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.

Sirolimus
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Participants who initiated Sirolimus
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Safety Population Number Analyzed 30 participants
52
(46 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
7
  23.3%
Male
23
  76.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 30 participants
White Non-Hispanic
8
  26.7%
Black Non-Hispanic
18
  60.0%
Hispanic
3
  10.0%
More than one race
1
   3.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
CD4+ T-cell counts   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 30 participants
818
(635 to 1031)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
HIV-1 Gag-specific CD8+ T-cells by intracellular staining for interferon (IFN)-gamma   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific IFN-gamma+ CD8+ T-cells
Number Analyzed 16 participants
0.1
(0.05 to 0.14)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
CD4+ T-cell-associated HIV-1 RNA   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Log10(copies/10^6 CD4+ T-cells)
Number Analyzed 16 participants
2.57
(2.19 to 3.13)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus
HIV-1 RNA by single-copy assay (SCA)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Study Entry Number Analyzed 16 participants
< 0.7 copies/mL
8
  50.0%
>= 0.7 copies/mL
8
  50.0%
Study Week 12 Number Analyzed 16 participants
< 0.7 copies/mL
9
  56.3%
>= 0.7 copies/mL
7
  43.8%
[1]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
HIV-1 RNA   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Study Entry Number Analyzed 16 participants
< 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
Study Week 12 Number Analyzed 16 participants
< 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
[1]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific IFN-gamma+ CD4+ T-cells
Number Analyzed 16 participants
0.04
(0.03 to 0.06)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific CD107a+ CD8+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific CD107a+ CD8+ T-cells
Number Analyzed 16 participants
0.01
(0 to 0.01)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific CD107a+ CD4+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific CD107a+ CD4+ T-cells
Number Analyzed 16 participants
0
(0 to 0.01)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific CD40L+ CD8+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific CD40L+CD8+ T-cells
Number Analyzed 16 participants
0.01
(0 to 0.03)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific CD40L+ CD4+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific CD40L+CD4+ T-cells
Number Analyzed 16 participants
0.09
(0.05 to 0.12)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific interleukin (IL)-2+ CD8+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific IL-2+ CD8+ T-cells
Number Analyzed 16 participants
0.01
(0 to 0.03)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific IL-2+ CD4+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific IL-2+ CD4+ T-cells
Number Analyzed 16 participants
0.02
(0.01 to 0.03)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific MIP1B+ CD8+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific MIP1B+ CD8+ T-cells
Number Analyzed 16 participants
0.06
(0.03 to 0.13)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific MIP1B+ CD4+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific MIP1B+ CD4+ T-cells
Number Analyzed 16 participants
0.01
(0 to 0.01)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific tumor necrosis factor (TNF)-alpha+ CD8+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific TNF-alpha CD8+ T-cells
Number Analyzed 16 participants
0.03
(0.02 to 0.05)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
GAG-specific TNF-alpha+ CD4+ T-Cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Gag-specific TNF-alpha CD4+ T-cells
Number Analyzed 16 participants
0.03
(0.02 to 0.04)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
%CD69+ CD4+ T-cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %CD69+ CD4+ T-cells
Number Analyzed 16 participants
5.5
(4.5 to 7.4)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
%CD69+ CD8+ T-cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %CD69+ CD8+ T-cells
Number Analyzed 16 participants
8.4
(7.2 to 9.9)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
%Ki67+ CD4+ T-cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Ki67+ CD4+ T-cells
Number Analyzed 16 participants
2.2
(1.9 to 2.7)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
%Ki67+ CD8+ T-cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %Ki67+ CD8+ T-cells
Number Analyzed 16 participants
1.6
(1.4 to 1.8)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
% programmed cell death protein 1 (PD1)+ CD4+ T-cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %PD1+ CD4+ T-cells
Number Analyzed 16 participants
39.7
(31.3 to 42.6)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
%PD1+ CD8+ T-cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  %PD1+ CD8+ T-cells
Number Analyzed 16 participants
27.8
(21 to 39.3)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
HIV-1 DNA levels in CD4+ T-cells   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Log10(copies/10^6 CD4+ T-cells)
Number Analyzed 16 participants
2.72
(2.08 to 3.1)
[1]
Measure Description: Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
[2]
Measure Analysis Population Description: n = 16 participants completed 20 weeks of Sirolimus.
1.Primary Outcome
Title Number of Participants Who Met the Study-defined Composite Safety Endpoint
Hide Description The study-defined primary safety endpoint was a composite endpoint. A participant was considered to have met the endpoint if the participant 1) experienced a new Grade ≥3 Adverse Event (AE), including signs/symptoms, lab toxicity or clinical event, that was definitely, probably or possibly related to study treatment, as judged by the core team, or 2) had a change in CD4+ cell count ( confirmed >50% decline or to <300 cells/mm3) while on sirolimus. The screening visit occurred within 60 days of study entry.
Time Frame Screening to study week 32 (week 20 of Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants Initiating Sirolimus.
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.0%
2.Primary Outcome
Title Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
Hide Description Frequency of HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific IFN-gamma+ CD8+ T-cells
Baseline Number Analyzed 16 participants
0.11  (0.08)
Week 20 on Sirolimus Number Analyzed 15 participants
0.11  (0.07)
3.Primary Outcome
Title Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
Hide Description Change in HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific IFN-gamma+ CD8+ T-cells
-0.01  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
4.Primary Outcome
Title Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA
Hide Description CD4+ T-cell-associated HIV-1 RNA. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: log10(copies/10^6 CD4+ T-cells)
Baseline 2.56  (0.67)
Week 20 on Sirolimus 2.35  (0.68)
5.Primary Outcome
Title Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA
Hide Description Change in CD4+ T-cell-associated HIV-1 RNA (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: log10(copies/10^6 CD4+ T-cells)
-0.21  (0.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
6.Primary Outcome
Title Efficacy - Virologic: Plasma HIV-1 RNA by SCA
Hide Description Plasma HIV-1 RNA by SCA
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Study week 0 < 0.7 copies/mL 8
>= 0.7 copies/mL 8
Study week 12 < 0.7 copies/mL 9
>= 0.7 copies/mL 7
Study week 32 (week 20 on Sirolimus) < 0.7 copies/mL 8
>= 0.7 copies/mL 8
7.Primary Outcome
Title Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA
Hide Description

Change in plasma HIV-1 RNA by SCA (week 32 measurement minus baseline measurement).

Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: log10(copies/mL)
-0.01  (0.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test; results less than the analysis lower limit (0.7 cp/mL) were imputed to a value of one half the analysis lower limit.
8.Secondary Outcome
Title Measurement of CD4+ T-cell Counts
Hide Description CD4+ T-cell counts. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Baseline 937  (402)
Study week 16 (week 4 on Sirolimus) 858  (403)
Study week 24 (week 12 on Sirolimus) 820  (378)
Study week 32 (week 20 on Sirolimus) 820  (377)
Study week 44 891  (320)
9.Secondary Outcome
Title Change in CD4+ T-cell Counts
Hide Description Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-118  (211)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
10.Secondary Outcome
Title Measurement of HIV-1 RNA Levels
Hide Description HIV-1 RNA levels by conventional assay
Time Frame weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Study Week 0 < 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
Study Week 12 < 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
Study Week 16 (Week 4 on Sirolimus) < 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
Study Week 24 (Week 12 on Sirolimus) < 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
Study Week 32 (Week 20 on Sirolimus) < 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
Study Week 44 < 40 copies/mL
16
 100.0%
>= 40 copies/mL
0
   0.0%
11.Secondary Outcome
Title Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
Hide Description HIV-1 DNA levels in CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: log10(copies/10^6 CD4+ T-cells)
Baseline 2.65  (0.71)
Study week 16 (week 4 on Sirolimus) 2.45  (0.81)
Study week 24 (week 12 on Sirolimus) 2.48  (0.78)
Study week 32 (week 20 on Sirolimus) 2.49  (0.75)
Study week 44 2.51  (0.79)
12.Secondary Outcome
Title Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
Hide Description Change in HIV-1 DNA levels in CD4+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: log10(copies/10^6 CD4+ T-cells)
-0.16  (0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
13.Secondary Outcome
Title Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %Gag-specific CD107a+ CD8+ T-cells
Baseline Number Analyzed 16 participants
0.01  (0.01)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.02  (0.02)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.01  (0.01)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.05  (0.14)
Study week 44 Number Analyzed 15 participants
0.02  (0.03)
14.Secondary Outcome
Title Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %Gag-specific CD107a+ CD8+ T-cells
0.04  (0.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
15.Secondary Outcome
Title Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %Gag-specific CD40L+ CD8+ T-cells
Baseline Number Analyzed 16 participants
0.02  (0.02)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
1.15  (4.53)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.01  (0.03)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.03  (0.05)
Study week 44 Number Analyzed 15 participants
0.01  (0.02)
16.Secondary Outcome
Title Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %Gag-specific CD40L+ CD8+ T-cells
0.01  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
17.Secondary Outcome
Title Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %Gag-specific IL-2+ CD8+ T-cells
Baseline Number Analyzed 16 participants
0.02  (0.03)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.01  (0.02)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.02  (0.02)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.02  (0.03)
Study week 44 Number Analyzed 15 participants
0.03  (0.04)
18.Secondary Outcome
Title Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %Gag-specific IL-2+ CD8+ T-cells
0  (0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
19.Secondary Outcome
Title Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific MIP1B+ CD8+ T-Cells
Baseline Number Analyzed 16 participants
0.09  (0.08)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.51  (1.72)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.08  (0.08)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.09  (0.08)
Study week 44 Number Analyzed 15 participants
0.08  (0.1)
20.Secondary Outcome
Title Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific MIP1B+ CD8+ T-Cells
-0.01  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
21.Secondary Outcome
Title Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific TNF-a+ CD8+ T-Cells
Baseline Number Analyzed 16 participants
0.04  (0.03)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.04  (0.03)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.03  (0.02)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.05  (0.05)
Study week 44 Number Analyzed 15 participants
0.04  (0.04)
22.Secondary Outcome
Title Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific TNF-a+ CD8+ T-Cells
0.01  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
23.Secondary Outcome
Title Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
Hide Description Frequency of HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific IFN-g+ CD4+ T-Cells
Baseline Number Analyzed 16 participants
0.06  (0.06)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.04  (0.03)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.05  (0.06)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.06  (0.05)
Study week 44 Number Analyzed 15 participants
0.04  (0.04)
24.Secondary Outcome
Title Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
Hide Description Change in HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific IFN-g+ CD4+ T-Cells
0  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
25.Secondary Outcome
Title Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific CD107a+ CD4+ T-Cells
Baseline Number Analyzed 16 participants
0.01  (0.01)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.01  (0.01)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.01  (0.01)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.03  (0.08)
Study week 44 Number Analyzed 15 participants
0.02  (0.02)
26.Secondary Outcome
Title Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific CD107a+ CD4+ T-Cells
0.02  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
27.Secondary Outcome
Title Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific CD40L+ CD4+ T-Cells
Baseline Number Analyzed 16 participants
0.08  (0.05)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.06  (0.06)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.1  (0.06)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.08  (0.07)
Study week 44 Number Analyzed 15 participants
0.08  (0.07)
28.Secondary Outcome
Title Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells (week 32 measurement minus baseline measurement).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific CD40L+ CD4+ T-Cells
-0.01  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
29.Secondary Outcome
Title Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific IL-2+ CD4+ T-Cells
Baseline Number Analyzed 16 participants
0.03  (0.05)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.04  (0.03)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.04  (0.07)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.08  (0.16)
Study week 44 Number Analyzed 15 participants
0.04  (0.05)
30.Secondary Outcome
Title Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific IL-2+ CD4+ T-Cells
0.04  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
31.Secondary Outcome
Title Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific MIP1B+ CD4+ T-Cells
Baseline Number Analyzed 16 participants
0.01  (0.01)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.01  (0.01)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.01  (0.02)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.01  (0.01)
Study week 44 Number Analyzed 15 participants
0.01  (0.01)
32.Secondary Outcome
Title Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells (week 32 measurement minus baseline measurement).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific MIP1B+ CD4+ T-Cells
0  (0.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
33.Secondary Outcome
Title Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
Hide Description Frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %GAG-specific TNF-alpha+ CD4+ T-Cells
Baseline Number Analyzed 16 participants
0.04  (0.03)
Study week 16 (week 4 on Sirolimus) Number Analyzed 16 participants
0.04  (0.03)
Study week 24 (week 12 on Sirolimus) Number Analyzed 16 participants
0.03  (0.04)
Study week 32 (week 20 on Sirolimus) Number Analyzed 15 participants
0.04  (0.03)
Study week 44 Number Analyzed 15 participants
0.04  (0.03)
34.Secondary Outcome
Title Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
Hide Description Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells (week 32 measurement minus baseline measurement).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: %GAG-specific TNF-alpha+ CD4+ T-Cells
0  (0.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
35.Secondary Outcome
Title Measurement of %CD69+ CD4+ T-cells
Hide Description Measurement of %CD69+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %CD69+ CD4+ T-Cells
Baseline 6.3  (2.6)
Study week 16 (week 4 on Sirolimus) 6.1  (2.3)
Study week 24 (week 12 on Sirolimus) 5.8  (2.0)
Study week 32 (week 20 on Sirolimus) 6.1  (1.9)
Study week 44 5.9  (2.3)
36.Secondary Outcome
Title Change in of %CD69+ CD4+ T-cells
Hide Description Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %CD69+ CD4+ T-Cells
-0.17  (1.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
37.Secondary Outcome
Title Measurement of %CD69+ CD8+ T-cells
Hide Description Measurement of %CD69+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %CD69+ CD8+ T-Cells
Baseline 8.6  (2.9)
Study week 16 (week 4 on Sirolimus) 8.4  (2.8)
Study week 24 (week 12 on Sirolimus) 7.9  (2.5)
Study week 32 (week 20 on Sirolimus) 8.1  (2.5)
Study week 44 8.2  (2.4)
38.Secondary Outcome
Title Change in of %CD69+ CD8+ T-cells
Hide Description Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %CD69+ CD8+ T-Cells
-0.52  (1.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
39.Secondary Outcome
Title Measurement of %Ki67+ CD4+ T-cells
Hide Description Measurement of %Ki67+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %Ki67+ CD4+ T-Cells
Baseline 2.4  (0.8)
Study week 16 (week 4 on Sirolimus) 2.2  (0.9)
Study week 24 (week 12 on Sirolimus) 2.2  (0.8)
Study week 32 (week 20 on Sirolimus) 1.9  (0.8)
Study week 44 2.4  (1)
40.Secondary Outcome
Title Change in of %Ki67+ CD4+ T-cells
Hide Description Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement).
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %Ki67+ CD4+ T-Cells
-0.51  (0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
41.Secondary Outcome
Title Measurement of %Ki67+ CD8+ T-cells
Hide Description Measurement of %Ki67+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %Ki67+ CD8+ T-Cells
Baseline 1.8  (0.8)
Study week 16 (week 4 on Sirolimus) 1  (0.4)
Study week 24 (week 12 on Sirolimus) 1.4  (0.7)
Study week 32 (week 20 on Sirolimus) 1.2  (0.6)
Study week 44 1.7  (0.7)
42.Secondary Outcome
Title Change in of %Ki67+ CD8+ T-cells
Hide Description Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %Ki67+ CD8+ T-Cells
-0.54  (0.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
43.Secondary Outcome
Title Measurement of %PD1+ CD4+ T-cells
Hide Description Measurement of %PD1+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %PD1+ CD4+ T-Cells
Baseline 38.4  (9.6)
Study week 16 (week 4 on Sirolimus) 39  (11.1)
Study week 24 (week 12 on Sirolimus) 38.8  (10.7)
Study week 32 (week 20 on Sirolimus) 38.8  (9.9)
Study week 44 35.5  (10.6)
44.Secondary Outcome
Title Change in of %PD1+ CD4+ T-cells
Hide Description Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %PD1+ CD4+ T-Cells
0.42  (4.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
45.Secondary Outcome
Title Measurement of %PD1+ CD8+ T-cells
Hide Description Measurement of %PD1+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
Time Frame At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %PD1+ CD8+ T-Cells
Baseline 29.4  (10.2)
Study week 16 (week 4 on Sirolimus) 28.4  (9.9)
Study week 24 (week 12 on Sirolimus) 28.4  (10.6)
Study week 32 (week 20 on Sirolimus) 26.6  (9.9)
Study week 44 25.5  (8.7)
46.Secondary Outcome
Title Change in of %PD1+ CD8+ T-cells
Hide Description Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement)
Time Frame At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 20 weeks of Sirolimus
Arm/Group Title Sirolimus
Hide Arm/Group Description:

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: %PD1+ CD8+ T-Cells
-2.85  (3.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sirolimus
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments paired t-test
Time Frame Screening to study week 32 (week 20 of Sirolimus)
Adverse Event Reporting Description

At entry, all grades of signs and symptoms that occurred within 30 days before entry were recorded; post-entry, all grades of Grade ≥2 were recorded. All Grade 3 or higher sign/symptom, any sign/symptom regardless of grade that led to a change in study treatment, or that met ICH, EAE or SAE guidelines were recorded. The DAIDS AE Grading Table Version 2.0 and Expedited AE Manual Version 2.0 were used.

All participants exposed to Sirolimus are included.
 
Arm/Group Title Sirolimus
Hide Arm/Group Description Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks. Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.
All-Cause Mortality
Sirolimus
Affected / at Risk (%)
Total   0/30 (0.00%) 
Hide Serious Adverse Events
Sirolimus
Affected / at Risk (%)
Total   1/30 (3.33%) 
Gastrointestinal disorders   
Diarrhoea † 1  1/30 (3.33%) 
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sirolimus
Affected / at Risk (%)
Total   28/30 (93.33%) 
Gastrointestinal disorders   
Diarrhoea † 1  3/30 (10.00%) 
Mouth ulceration † 1  2/30 (6.67%) 
General disorders   
Asthenia † 1  2/30 (6.67%) 
Chills † 1  2/30 (6.67%) 
Fatigue † 1  3/30 (10.00%) 
Malaise † 1  3/30 (10.00%) 
Pain † 1  3/30 (10.00%) 
Pyrexia † 1  2/30 (6.67%) 
Infections and infestations   
Viral upper respiratory tract infection † 1  3/30 (10.00%) 
Investigations   
Alanine aminotransferase increased † 1  3/30 (10.00%) 
Aspartate aminotransferase increased † 1  7/30 (23.33%) 
Blood alkaline phosphatase increased † 1  3/30 (10.00%) 
Blood cholesterol increased † 1  15/30 (50.00%) 
Blood creatine phosphokinase increased † 1  5/30 (16.67%) 
Blood creatinine increased † 1  3/30 (10.00%) 
Blood glucose decreased † 1  3/30 (10.00%) 
Blood glucose increased † 1  13/30 (43.33%) 
Blood pressure increased † 1  2/30 (6.67%) 
Blood sodium decreased † 1  3/30 (10.00%) 
Blood sodium increased † 1  2/30 (6.67%) 
Blood triglycerides increased † 1  18/30 (60.00%) 
Low density lipoprotein increased † 1  13/30 (43.33%) 
Weight decreased † 1  2/30 (6.67%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  3/30 (10.00%) 
Musculoskeletal and connective tissue disorders   
Joint swelling † 1  2/30 (6.67%) 
Renal and urinary disorders   
Pollakiuria † 1  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  4/30 (13.33%) 
Dyspnoea † 1  2/30 (6.67%) 
Nasal congestion † 1  2/30 (6.67%) 
Productive cough † 1  2/30 (6.67%) 
Rhinorrhoea † 1  3/30 (10.00%) 
Skin and subcutaneous tissue disorders   
Night sweats † 1  2/30 (6.67%) 
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Layout table for additonal information
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02440789    
Other Study ID Numbers: ACTG A5337
2UM1AI068636 ( U.S. NIH Grant/Contract )
First Submitted: April 6, 2015
First Posted: May 12, 2015
Results First Submitted: December 12, 2019
Results First Posted: December 30, 2019
Last Update Posted: August 3, 2021