| 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. | Participants Initiating Sirolimus. | Posted | | Count of Participants | | Participants | | Screening to study week 32 (week 20 of Sirolimus) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific IFN-gamma+ CD8+ T-cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific IFN-gamma+ CD8+ T-cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | log10(copies/10^6 CD4+ T-cells) | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | log10(copies/10^6 CD4+ T-cells) | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Primary | Efficacy - Virologic: Plasma HIV-1 RNA by SCA | | Participants completing 20 weeks of Sirolimus | Posted | | Count of Participants | | Participants | No | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | log10(copies/mL) | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | cells/mm^3 | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Change in CD4+ T-cell Counts | Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | cells/mm^3 | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Measurement of HIV-1 RNA Levels | HIV-1 RNA levels by conventional assay | Participants completing 20 weeks of Sirolimus | Posted | | Count of Participants | | Participants | | weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | log10(copies/10^6 CD4+ T-cells) | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | log10(copies/10^6 CD4+ T-cells) | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Gag-specific CD107a+ CD8+ T-cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Gag-specific CD107a+ CD8+ T-cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Gag-specific CD40L+ CD8+ T-cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Gag-specific CD40L+ CD8+ T-cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Gag-specific IL-2+ CD8+ T-cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Gag-specific IL-2+ CD8+ T-cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific MIP1B+ CD8+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific MIP1B+ CD8+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific TNF-a+ CD8+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific TNF-a+ CD8+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific IFN-g+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific IFN-g+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific CD107a+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific CD107a+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific CD40L+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific CD40L+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific IL-2+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific IL-2+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific MIP1B+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific MIP1B+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific TNF-alpha+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %GAG-specific TNF-alpha+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %CD69+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Change in of %CD69+ CD4+ T-cells | Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %CD69+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %CD69+ CD8+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in of %CD69+ CD8+ T-cells | Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %CD69+ CD8+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Ki67+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in of %Ki67+ CD4+ T-cells | Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Ki67+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Ki67+ CD8+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in of %Ki67+ CD8+ T-cells | Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %Ki67+ CD8+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %PD1+ CD4+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in of %PD1+ CD4+ T-cells | Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %PD1+ CD4+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %PD1+ CD8+ T-Cells | | At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in of %PD1+ CD8+ T-cells | Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement) | Participants completing 20 weeks of Sirolimus | Posted | | Mean | Standard Deviation | %PD1+ CD8+ T-Cells | | At study weeks 0, 12 and 32 (week 20 on Sirolimus) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |