HIV-1 Infection
Conditions
Brief summary
The purpose of this study was to find out about the safety of sirolimus in individuals with HIV infection who were also being treated with ART. The investigators wanted to learn whether sirolimus decreases inflammation and immune activation in the body; whether sirolimus changes the level of HIV in the participants' blood; and how sirolimus interacts with ART in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus had also been used for the prevention of complications after stem cell transplants and as a treatment for certain kinds of cancers in HIV-infected patients.
Detailed description
The study was conducted with an initial lead-in period of 12 weeks where participants remained on ART, without study intervention. Samples were collected to define the pre-intervention steady-state of HIV, inflammation and immune activation parameters. At week 12, sirolimus therapy was initiated for the planned 20 weeks of treatment. In order to achieve therapeutic levels, sirolimus therapy was initiated with lead-in dose of 0.025 or 0.05 mg/kg/day, depending on the ART regimen. Doses for each participant were then adjusted, based on trough blood sirolimus concentrations, to achieve target concentrations between 5 and 10 ng/mL. There were frequent initial visits for sirolimus trough concentration monitoring and potential dose adjustments, at weeks 12.5, 13, 13.5, 14, 14.5, 15, 15.5 and 16. Then visits occurred at weeks 18, 20, 24, 28 and 32. After the week 32 visit, the planned end of study treatment, there was an additional 12 weeks of post-sirolimus follow-up, with a final visit at week 44. Study visits included physical examinations, clinical assessments, safety monitoring, and blood and oral swab collection. Anal swabs were collected at week 12 and 32. Samples were stored for subsequent protocol testing for the study outcomes. In the primary analysis, the significance level was 0.05 for all analyses.
Interventions
DRUGSirolimus
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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 infection * On continuous ART for ≥24 months prior to study entry. * CD4+ cell count ≥350 cells/mm\^3 * Plasma HIV-1 RNA below the level of quantification for ≥24 months. * White blood cell (WBC) ≥3000/mm\^3 * Platelet count ≥125,000/mm\^3 * Absolute neutrophil count (ANC) \>1300/mm\^3 * Aspartate aminotransferase (AST) \<1.25 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) \<1.25 x ULN * Calculated creatinine clearance (CrCl) ≥60 mL/min * Fasting or non-fasting triglyceride level ≤350 mg/dL * Fasting or non-fasting LDL \<160 mg/dL * Urine protein to urine creatinine ratio ≤1 g/g from random urine collection
Exclusion criteria
* Serious illness requiring systemic treatment and/or hospitalization * Documentation of any CDC Category C AIDS-indicator condition or oropharyngeal candidiasis (thrush) * Intended modification of ART during the study. * Latent tuberculosis (TB) infection * TB disease within 48 weeks prior to study entry requiring treatment. * History of active hepatitis B (HBV) infection. * Hepatitis C virus (HCV) RNA-positive * Previous myelodysplasia syndrome, lymphoproliferative disease, lung disease, malignancies, congestive heart failure, life-threatening fungal infection or herpes-zoster/varicella-zoster viral infection requiring treatment. * Detectable Epstein-Barr virus (EBV) in blood * Active infection other than HIV that required receipt of systemic antibiotic therapy by intravenous infusion * History of major hypersensitivity reaction to macrolide drugs including angioedema, anaphylaxis, drug-induced dermatitis, or hypersensitivity vasculitis. * Currently pregnant or breastfeeding, or planning to become pregnant prior to or during the study. * Use of immunomodulators (eg, interleukins, interferons, and cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy. * Active drug or alcohol use or dependence * Vaccination within 14 days prior to study entry. * On or planned to change to a PI-based ART or cobicistat-boosted regimen * Anti-human papillomavirus (HPV) therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Met the Study-defined Composite Safety Endpoint | Screening to study week 32 (week 20 of Sirolimus) | 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. |
| Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | 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). |
| Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement) |
| Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | CD4+ T-cell-associated HIV-1 RNA. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in CD4+ T-cell-associated HIV-1 RNA (week 32 measurement minus baseline measurement) |
| Efficacy - Virologic: Plasma HIV-1 RNA by SCA | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Plasma HIV-1 RNA by SCA |
| Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells (week 32 measurement minus baseline measurement). |
| Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells (week 32 measurement minus baseline measurement). |
| Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells (week 32 measurement minus baseline measurement). |
| Measurement of %CD69+ CD4+ T-cells | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | Measurement of %CD69+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Measurement of CD4+ T-cell Counts | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | CD4+ T-cell counts. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Measurement of %CD69+ CD8+ T-cells | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | Measurement of %CD69+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Change in of %CD69+ CD8+ T-cells | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of %Ki67+ CD4+ T-cells | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | Measurement of %Ki67+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Change in of %Ki67+ CD4+ T-cells | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement). |
| Measurement of %Ki67+ CD8+ T-cells | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | Measurement of %Ki67+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Change in of %Ki67+ CD8+ T-cells | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of %PD1+ CD4+ T-cells | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | Measurement of %PD1+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Change in of %PD1+ CD4+ T-cells | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of %PD1+ CD8+ T-cells | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | Measurement of %PD1+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Change in of %PD1+ CD8+ T-cells | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
| Change in of %CD69+ CD4+ T-cells | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement). |
| Change in CD4+ T-cell Counts | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 RNA Levels | weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44 | HIV-1 RNA levels by conventional assay |
| Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | HIV-1 DNA levels in CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12). |
| Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in HIV-1 DNA levels in CD4+ T-cells (week 32 measurement minus baseline measurement) |
| Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | 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). |
| Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | Change in frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells (week 32 measurement minus baseline measurement) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 10 Clinical Research Sites (CRSs) in the United States between December 2015 and March 2017.
Participants by arm
| Arm | Count |
|---|---|
| Sirolimus 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 | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not willing to adhere to reqs | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Sirolimus |
|---|---|
| Age, Continuous Safety Population | 52 years |
| CD4+ T-cell-associated HIV-1 RNA | 2.57 log10(copies/10^6 CD4+ T-cells) |
| CD4+ T-cell counts | 818 cells/mm^3 |
| %CD69+ CD4+ T-cells | 5.5 %CD69+ CD4+ T-cells |
| %CD69+ CD8+ T-cells | 8.4 %CD69+ CD8+ T-cells |
| GAG-specific CD107a+ CD4+ T-Cells | 0 %Gag-specific CD107a+ CD4+ T-cells |
| GAG-specific CD107a+ CD8+ T-Cells | 0.01 %Gag-specific CD107a+ CD8+ T-cells |
| GAG-specific CD40L+ CD4+ T-Cells | 0.09 %Gag-specific CD40L+CD4+ T-cells |
| GAG-specific CD40L+ CD8+ T-Cells | 0.01 %Gag-specific CD40L+CD8+ T-cells |
| GAG-specific IL-2+ CD4+ T-Cells | 0.02 %Gag-specific IL-2+ CD4+ T-cells |
| GAG-specific interleukin (IL)-2+ CD8+ T-Cells | 0.01 %Gag-specific IL-2+ CD8+ T-cells |
| GAG-specific MIP1B+ CD4+ T-Cells | 0.01 %Gag-specific MIP1B+ CD4+ T-cells |
| GAG-specific MIP1B+ CD8+ T-Cells | 0.06 %Gag-specific MIP1B+ CD8+ T-cells |
| GAG-specific TNF-alpha+ CD4+ T-Cells | 0.03 %Gag-specific TNF-alpha CD4+ T-cells |
| GAG-specific tumor necrosis factor (TNF)-alpha+ CD8+ T-Cells | 0.03 %Gag-specific TNF-alpha CD8+ T-cells |
| HIV-1 DNA levels in CD4+ T-cells | 2.72 log10(copies/10^6 CD4+ T-cells) |
| HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma | 0.04 %Gag-specific IFN-gamma+ CD4+ T-cells |
| HIV-1 Gag-specific CD8+ T-cells by intracellular staining for interferon (IFN)-gamma | 0.1 %Gag-specific IFN-gamma+ CD8+ T-cells |
| HIV-1 RNA Study Entry < 40 copies/mL | 16 Participants |
| HIV-1 RNA Study Entry >= 40 copies/mL | 0 Participants |
| HIV-1 RNA Study Week 12 < 40 copies/mL | 16 Participants |
| HIV-1 RNA Study Week 12 >= 40 copies/mL | 0 Participants |
| HIV-1 RNA by single-copy assay (SCA) Study Entry < 0.7 copies/mL | 8 Participants |
| HIV-1 RNA by single-copy assay (SCA) Study Entry >= 0.7 copies/mL | 8 Participants |
| HIV-1 RNA by single-copy assay (SCA) Study Week 12 < 0.7 copies/mL | 9 Participants |
| HIV-1 RNA by single-copy assay (SCA) Study Week 12 >= 0.7 copies/mL | 7 Participants |
| %Ki67+ CD4+ T-cells | 2.2 %Ki67+ CD4+ T-cells |
| %Ki67+ CD8+ T-cells | 1.6 %Ki67+ CD8+ T-cells |
| %PD1+ CD8+ T-cells | 27.8 %PD1+ CD8+ T-cells |
| % programmed cell death protein 1 (PD1)+ CD4+ T-cells | 39.7 %PD1+ CD4+ T-cells |
| Race/Ethnicity, Customized Race/Ethnicity Black Non-Hispanic | 18 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity More than one race | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White Non-Hispanic | 8 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 28 / 30 |
| serious Total, serious adverse events | 1 / 30 |
Outcome results
Primary
Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma | -0.01 %GAG-specific IFN-gamma+ CD8+ T-cells | Standard Deviation 0.06 |
p-value: 0.56t-test, 2 sided
Primary
Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma | Baseline | 0.11 %GAG-specific IFN-gamma+ CD8+ T-cells | Standard Deviation 0.08 |
| Sirolimus | Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma | Week 20 on Sirolimus | 0.11 %GAG-specific IFN-gamma+ CD8+ T-cells | Standard Deviation 0.07 |
Primary
Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA | Baseline | 2.56 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.67 |
| Sirolimus | Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA | Week 20 on Sirolimus | 2.35 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.68 |
Primary
Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA | -0.21 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.48 |
p-value: 0.11t-test, 2 sided
Primary
Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA | -0.01 log10(copies/mL) | Standard Deviation 0.47 |
p-value: 0.93t-test, 2 sided
Primary
Efficacy - Virologic: Plasma HIV-1 RNA by SCA
Plasma HIV-1 RNA by SCA
Time frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sirolimus | Efficacy - Virologic: Plasma HIV-1 RNA by SCA | Study week 0 | >= 0.7 copies/mL | 8 Participants |
| Sirolimus | Efficacy - Virologic: Plasma HIV-1 RNA by SCA | Study week 12 | < 0.7 copies/mL | 9 Participants |
| Sirolimus | Efficacy - Virologic: Plasma HIV-1 RNA by SCA | Study week 12 | >= 0.7 copies/mL | 7 Participants |
| Sirolimus | Efficacy - Virologic: Plasma HIV-1 RNA by SCA | Study week 32 (week 20 on Sirolimus) | < 0.7 copies/mL | 8 Participants |
| Sirolimus | Efficacy - Virologic: Plasma HIV-1 RNA by SCA | Study week 0 | < 0.7 copies/mL | 8 Participants |
| Sirolimus | Efficacy - Virologic: Plasma HIV-1 RNA by SCA | Study week 32 (week 20 on Sirolimus) | >= 0.7 copies/mL | 8 Participants |
Primary
Number of Participants Who Met the Study-defined Composite Safety Endpoint
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)
Population: Participants Initiating Sirolimus.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sirolimus | Number of Participants Who Met the Study-defined Composite Safety Endpoint | 3 Participants |
Secondary
Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | Baseline | 2.65 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.71 |
| Sirolimus | Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | Study week 16 (week 4 on Sirolimus) | 2.45 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.81 |
| Sirolimus | Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | Study week 24 (week 12 on Sirolimus) | 2.48 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.78 |
| Sirolimus | Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | Study week 32 (week 20 on Sirolimus) | 2.49 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.75 |
| Sirolimus | Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | Study week 44 | 2.51 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.79 |
Secondary
Change in CD4+ T-cell Counts
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in CD4+ T-cell Counts | -118 cells/mm^3 | Standard Deviation 211 |
p-value: 0.041t-test, 2 sided
Secondary
Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells | -0.16 log10(copies/10^6 CD4+ T-cells) | Standard Deviation 0.21 |
p-value: 0.008t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | 0.02 %GAG-specific CD107a+ CD4+ T-Cells | Standard Deviation 0.08 |
p-value: 0.28t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | 0.04 %Gag-specific CD107a+ CD8+ T-cells | Standard Deviation 0.14 |
p-value: 0.26t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | -0.01 %GAG-specific CD40L+ CD4+ T-Cells | Standard Deviation 0.07 |
p-value: 0.7t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | 0.01 %Gag-specific CD40L+ CD8+ T-cells | Standard Deviation 0.06 |
p-value: 0.75t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | 0 %GAG-specific IFN-g+ CD4+ T-Cells | Standard Deviation 0.04 |
p-value: 0.72t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | 0.04 %GAG-specific IL-2+ CD4+ T-Cells | Standard Deviation 0.15 |
p-value: 0.28t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | 0 %Gag-specific IL-2+ CD8+ T-cells | Standard Deviation 0.05 |
p-value: 0.97t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | 0 %GAG-specific MIP1B+ CD4+ T-Cells | Standard Deviation 0.01 |
p-value: 0.77t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | -0.01 %GAG-specific MIP1B+ CD8+ T-Cells | Standard Deviation 0.06 |
p-value: 0.7t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | 0 %GAG-specific TNF-alpha+ CD4+ T-Cells | Standard Deviation 0.02 |
p-value: 0.93t-test, 2 sided
Secondary
Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | 0.01 %GAG-specific TNF-a+ CD8+ T-Cells | Standard Deviation 0.04 |
p-value: 0.47t-test, 2 sided
Secondary
Change in of %CD69+ CD4+ T-cells
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in of %CD69+ CD4+ T-cells | -0.17 %CD69+ CD4+ T-Cells | Standard Deviation 1.51 |
p-value: 0.65t-test, 2 sided
Secondary
Change in of %CD69+ CD8+ T-cells
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in of %CD69+ CD8+ T-cells | -0.52 %CD69+ CD8+ T-Cells | Standard Deviation 1.63 |
p-value: 0.22t-test, 2 sided
Secondary
Change in of %Ki67+ CD4+ T-cells
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in of %Ki67+ CD4+ T-cells | -0.51 %Ki67+ CD4+ T-Cells | Standard Deviation 0.86 |
p-value: 0.031t-test, 2 sided
Secondary
Change in of %Ki67+ CD8+ T-cells
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in of %Ki67+ CD8+ T-cells | -0.54 %Ki67+ CD8+ T-Cells | Standard Deviation 0.67 |
p-value: 0.005t-test, 2 sided
Secondary
Change in of %PD1+ CD4+ T-cells
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in of %PD1+ CD4+ T-cells | 0.42 %PD1+ CD4+ T-Cells | Standard Deviation 4.19 |
p-value: 0.69t-test, 2 sided
Secondary
Change in of %PD1+ CD8+ T-cells
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)
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus | Change in of %PD1+ CD8+ T-cells | -2.85 %PD1+ CD8+ T-Cells | Standard Deviation 3.74 |
p-value: 0.008t-test, 2 sided
Secondary
Measurement of CD4+ T-cell Counts
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of CD4+ T-cell Counts | Baseline | 937 cells/mm^3 | Standard Deviation 402 |
| Sirolimus | Measurement of CD4+ T-cell Counts | Study week 16 (week 4 on Sirolimus) | 858 cells/mm^3 | Standard Deviation 403 |
| Sirolimus | Measurement of CD4+ T-cell Counts | Study week 24 (week 12 on Sirolimus) | 820 cells/mm^3 | Standard Deviation 378 |
| Sirolimus | Measurement of CD4+ T-cell Counts | Study week 32 (week 20 on Sirolimus) | 820 cells/mm^3 | Standard Deviation 377 |
| Sirolimus | Measurement of CD4+ T-cell Counts | Study week 44 | 891 cells/mm^3 | Standard Deviation 320 |
Secondary
Measurement of %CD69+ CD4+ T-cells
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of %CD69+ CD4+ T-cells | Baseline | 6.3 %CD69+ CD4+ T-Cells | Standard Deviation 2.6 |
| Sirolimus | Measurement of %CD69+ CD4+ T-cells | Study week 16 (week 4 on Sirolimus) | 6.1 %CD69+ CD4+ T-Cells | Standard Deviation 2.3 |
| Sirolimus | Measurement of %CD69+ CD4+ T-cells | Study week 24 (week 12 on Sirolimus) | 5.8 %CD69+ CD4+ T-Cells | Standard Deviation 2 |
| Sirolimus | Measurement of %CD69+ CD4+ T-cells | Study week 32 (week 20 on Sirolimus) | 6.1 %CD69+ CD4+ T-Cells | Standard Deviation 1.9 |
| Sirolimus | Measurement of %CD69+ CD4+ T-cells | Study week 44 | 5.9 %CD69+ CD4+ T-Cells | Standard Deviation 2.3 |
Secondary
Measurement of %CD69+ CD8+ T-cells
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of %CD69+ CD8+ T-cells | Baseline | 8.6 %CD69+ CD8+ T-Cells | Standard Deviation 2.9 |
| Sirolimus | Measurement of %CD69+ CD8+ T-cells | Study week 16 (week 4 on Sirolimus) | 8.4 %CD69+ CD8+ T-Cells | Standard Deviation 2.8 |
| Sirolimus | Measurement of %CD69+ CD8+ T-cells | Study week 24 (week 12 on Sirolimus) | 7.9 %CD69+ CD8+ T-Cells | Standard Deviation 2.5 |
| Sirolimus | Measurement of %CD69+ CD8+ T-cells | Study week 32 (week 20 on Sirolimus) | 8.1 %CD69+ CD8+ T-Cells | Standard Deviation 2.5 |
| Sirolimus | Measurement of %CD69+ CD8+ T-cells | Study week 44 | 8.2 %CD69+ CD8+ T-Cells | Standard Deviation 2.4 |
Secondary
Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | Baseline | 0.01 %GAG-specific CD107a+ CD4+ T-Cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.01 %GAG-specific CD107a+ CD4+ T-Cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.01 %GAG-specific CD107a+ CD4+ T-Cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.03 %GAG-specific CD107a+ CD4+ T-Cells | Standard Deviation 0.08 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses | Study week 44 | 0.02 %GAG-specific CD107a+ CD4+ T-Cells | Standard Deviation 0.02 |
Secondary
Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | Baseline | 0.01 %Gag-specific CD107a+ CD8+ T-cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.02 %Gag-specific CD107a+ CD8+ T-cells | Standard Deviation 0.02 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.01 %Gag-specific CD107a+ CD8+ T-cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.05 %Gag-specific CD107a+ CD8+ T-cells | Standard Deviation 0.14 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses | Study week 44 | 0.02 %Gag-specific CD107a+ CD8+ T-cells | Standard Deviation 0.03 |
Secondary
Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | Baseline | 0.08 %GAG-specific CD40L+ CD4+ T-Cells | Standard Deviation 0.05 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.06 %GAG-specific CD40L+ CD4+ T-Cells | Standard Deviation 0.06 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.1 %GAG-specific CD40L+ CD4+ T-Cells | Standard Deviation 0.06 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.08 %GAG-specific CD40L+ CD4+ T-Cells | Standard Deviation 0.07 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses | Study week 44 | 0.08 %GAG-specific CD40L+ CD4+ T-Cells | Standard Deviation 0.07 |
Secondary
Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | Baseline | 0.02 %Gag-specific CD40L+ CD8+ T-cells | Standard Deviation 0.02 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 1.15 %Gag-specific CD40L+ CD8+ T-cells | Standard Deviation 4.53 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.01 %Gag-specific CD40L+ CD8+ T-cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.03 %Gag-specific CD40L+ CD8+ T-cells | Standard Deviation 0.05 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses | Study week 44 | 0.01 %Gag-specific CD40L+ CD8+ T-cells | Standard Deviation 0.02 |
Secondary
Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | Baseline | 0.06 %GAG-specific IFN-g+ CD4+ T-Cells | Standard Deviation 0.06 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | Study week 16 (week 4 on Sirolimus) | 0.04 %GAG-specific IFN-g+ CD4+ T-Cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | Study week 24 (week 12 on Sirolimus) | 0.05 %GAG-specific IFN-g+ CD4+ T-Cells | Standard Deviation 0.06 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | Study week 32 (week 20 on Sirolimus) | 0.06 %GAG-specific IFN-g+ CD4+ T-Cells | Standard Deviation 0.05 |
| Sirolimus | Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses | Study week 44 | 0.04 %GAG-specific IFN-g+ CD4+ T-Cells | Standard Deviation 0.04 |
Secondary
Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | Baseline | 0.03 %GAG-specific IL-2+ CD4+ T-Cells | Standard Deviation 0.05 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.04 %GAG-specific IL-2+ CD4+ T-Cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.04 %GAG-specific IL-2+ CD4+ T-Cells | Standard Deviation 0.07 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.08 %GAG-specific IL-2+ CD4+ T-Cells | Standard Deviation 0.16 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses | Study week 44 | 0.04 %GAG-specific IL-2+ CD4+ T-Cells | Standard Deviation 0.05 |
Secondary
Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | Study week 44 | 0.03 %Gag-specific IL-2+ CD8+ T-cells | Standard Deviation 0.04 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | Baseline | 0.02 %Gag-specific IL-2+ CD8+ T-cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.01 %Gag-specific IL-2+ CD8+ T-cells | Standard Deviation 0.02 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.02 %Gag-specific IL-2+ CD8+ T-cells | Standard Deviation 0.02 |
| Sirolimus | Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.02 %Gag-specific IL-2+ CD8+ T-cells | Standard Deviation 0.03 |
Secondary
Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | Baseline | 0.01 %GAG-specific MIP1B+ CD4+ T-Cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.01 %GAG-specific MIP1B+ CD4+ T-Cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.01 %GAG-specific MIP1B+ CD4+ T-Cells | Standard Deviation 0.02 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.01 %GAG-specific MIP1B+ CD4+ T-Cells | Standard Deviation 0.01 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses | Study week 44 | 0.01 %GAG-specific MIP1B+ CD4+ T-Cells | Standard Deviation 0.01 |
Secondary
Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | Baseline | 0.09 %GAG-specific MIP1B+ CD8+ T-Cells | Standard Deviation 0.08 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.51 %GAG-specific MIP1B+ CD8+ T-Cells | Standard Deviation 1.72 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.08 %GAG-specific MIP1B+ CD8+ T-Cells | Standard Deviation 0.08 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.09 %GAG-specific MIP1B+ CD8+ T-Cells | Standard Deviation 0.08 |
| Sirolimus | Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses | Study week 44 | 0.08 %GAG-specific MIP1B+ CD8+ T-Cells | Standard Deviation 0.1 |
Secondary
Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | Baseline | 0.04 %GAG-specific TNF-alpha+ CD4+ T-Cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.04 %GAG-specific TNF-alpha+ CD4+ T-Cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.03 %GAG-specific TNF-alpha+ CD4+ T-Cells | Standard Deviation 0.04 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.04 %GAG-specific TNF-alpha+ CD4+ T-Cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses | Study week 44 | 0.04 %GAG-specific TNF-alpha+ CD4+ T-Cells | Standard Deviation 0.03 |
Secondary
Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | Baseline | 0.04 %GAG-specific TNF-a+ CD8+ T-Cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | Study week 16 (week 4 on Sirolimus) | 0.04 %GAG-specific TNF-a+ CD8+ T-Cells | Standard Deviation 0.03 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | Study week 24 (week 12 on Sirolimus) | 0.03 %GAG-specific TNF-a+ CD8+ T-Cells | Standard Deviation 0.02 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | Study week 32 (week 20 on Sirolimus) | 0.05 %GAG-specific TNF-a+ CD8+ T-Cells | Standard Deviation 0.05 |
| Sirolimus | Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses | Study week 44 | 0.04 %GAG-specific TNF-a+ CD8+ T-Cells | Standard Deviation 0.04 |
Secondary
Measurement of HIV-1 RNA Levels
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 0 | < 40 copies/mL | 16 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 0 | >= 40 copies/mL | 0 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 12 | < 40 copies/mL | 16 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 12 | >= 40 copies/mL | 0 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 16 (Week 4 on Sirolimus) | < 40 copies/mL | 16 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 16 (Week 4 on Sirolimus) | >= 40 copies/mL | 0 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 24 (Week 12 on Sirolimus) | < 40 copies/mL | 16 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 24 (Week 12 on Sirolimus) | >= 40 copies/mL | 0 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 32 (Week 20 on Sirolimus) | < 40 copies/mL | 16 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 32 (Week 20 on Sirolimus) | >= 40 copies/mL | 0 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 44 | < 40 copies/mL | 16 Participants |
| Sirolimus | Measurement of HIV-1 RNA Levels | Study Week 44 | >= 40 copies/mL | 0 Participants |
Secondary
Measurement of %Ki67+ CD4+ T-cells
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of %Ki67+ CD4+ T-cells | Study week 16 (week 4 on Sirolimus) | 2.2 %Ki67+ CD4+ T-Cells | Standard Deviation 0.9 |
| Sirolimus | Measurement of %Ki67+ CD4+ T-cells | Baseline | 2.4 %Ki67+ CD4+ T-Cells | Standard Deviation 0.8 |
| Sirolimus | Measurement of %Ki67+ CD4+ T-cells | Study week 24 (week 12 on Sirolimus) | 2.2 %Ki67+ CD4+ T-Cells | Standard Deviation 0.8 |
| Sirolimus | Measurement of %Ki67+ CD4+ T-cells | Study week 32 (week 20 on Sirolimus) | 1.9 %Ki67+ CD4+ T-Cells | Standard Deviation 0.8 |
| Sirolimus | Measurement of %Ki67+ CD4+ T-cells | Study week 44 | 2.4 %Ki67+ CD4+ T-Cells | Standard Deviation 1 |
Secondary
Measurement of %Ki67+ CD8+ T-cells
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of %Ki67+ CD8+ T-cells | Baseline | 1.8 %Ki67+ CD8+ T-Cells | Standard Deviation 0.8 |
| Sirolimus | Measurement of %Ki67+ CD8+ T-cells | Study week 16 (week 4 on Sirolimus) | 1 %Ki67+ CD8+ T-Cells | Standard Deviation 0.4 |
| Sirolimus | Measurement of %Ki67+ CD8+ T-cells | Study week 24 (week 12 on Sirolimus) | 1.4 %Ki67+ CD8+ T-Cells | Standard Deviation 0.7 |
| Sirolimus | Measurement of %Ki67+ CD8+ T-cells | Study week 32 (week 20 on Sirolimus) | 1.2 %Ki67+ CD8+ T-Cells | Standard Deviation 0.6 |
| Sirolimus | Measurement of %Ki67+ CD8+ T-cells | Study week 44 | 1.7 %Ki67+ CD8+ T-Cells | Standard Deviation 0.7 |
Secondary
Measurement of %PD1+ CD4+ T-cells
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of %PD1+ CD4+ T-cells | Baseline | 38.4 %PD1+ CD4+ T-Cells | Standard Deviation 9.6 |
| Sirolimus | Measurement of %PD1+ CD4+ T-cells | Study week 16 (week 4 on Sirolimus) | 39 %PD1+ CD4+ T-Cells | Standard Deviation 11.1 |
| Sirolimus | Measurement of %PD1+ CD4+ T-cells | Study week 24 (week 12 on Sirolimus) | 38.8 %PD1+ CD4+ T-Cells | Standard Deviation 10.7 |
| Sirolimus | Measurement of %PD1+ CD4+ T-cells | Study week 32 (week 20 on Sirolimus) | 38.8 %PD1+ CD4+ T-Cells | Standard Deviation 9.9 |
| Sirolimus | Measurement of %PD1+ CD4+ T-cells | Study week 44 | 35.5 %PD1+ CD4+ T-Cells | Standard Deviation 10.6 |
Secondary
Measurement of %PD1+ CD8+ T-cells
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
Population: Participants completing 20 weeks of Sirolimus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sirolimus | Measurement of %PD1+ CD8+ T-cells | Baseline | 29.4 %PD1+ CD8+ T-Cells | Standard Deviation 10.2 |
| Sirolimus | Measurement of %PD1+ CD8+ T-cells | Study week 16 (week 4 on Sirolimus) | 28.4 %PD1+ CD8+ T-Cells | Standard Deviation 9.9 |
| Sirolimus | Measurement of %PD1+ CD8+ T-cells | Study week 24 (week 12 on Sirolimus) | 28.4 %PD1+ CD8+ T-Cells | Standard Deviation 10.6 |
| Sirolimus | Measurement of %PD1+ CD8+ T-cells | Study week 32 (week 20 on Sirolimus) | 26.6 %PD1+ CD8+ T-Cells | Standard Deviation 9.9 |
| Sirolimus | Measurement of %PD1+ CD8+ T-cells | Study week 44 | 25.5 %PD1+ CD8+ T-Cells | Standard Deviation 8.7 |