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

2021. július 30. frissítette: AIDS Clinical Trials Group

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

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

32

Fázis

  • 2. fázis
  • 1. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Egyesült Államok
    • California
      • San Francisco, California, Egyesült Államok, 94110
        • 801 University of California, San Francisco HIV/AIDS CRS
    • District of Columbia
      • Washington, District of Columbia, Egyesült Államok, 20005
        • Whitman Walker Health CRS (31791)
    • Florida
      • Miami, Florida, Egyesült Államok, 33136
        • Univ. of Miami AIDS CRS (901)
    • Georgia
      • Atlanta, Georgia, Egyesült Államok, 30308
        • The Ponce de Leon Center CRS (5802)
    • Missouri
      • Saint Louis, Missouri, Egyesült Államok, 63110
        • Washington University CRS (2101)
    • New York
      • New York, New York, Egyesült Államok, 10011
        • Weill Cornell Uptown CRS (7803)
      • Rochester, New York, Egyesült Államok, 14642
        • 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS
    • Ohio
      • Cincinnati, Ohio, Egyesült Államok, 45267
        • Univ. of Cincinnati CRS (2401)
    • Texas
      • Houston, Texas, Egyesült Államok, 77030
        • Houston AIDS Research Team CRS (31473)
    • Washington
      • Seattle, Washington, Egyesült Államok, 98104
        • University of Washington AIDS CRS (1401)

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Sirolimus
Drog: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Participants Who Met the Study-defined Composite Safety Endpoint
Időkeret: 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.
Screening to study week 32 (week 20 of Sirolimus)
Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
Időkeret: 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).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA
Időkeret: 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).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Plasma HIV-1 RNA by SCA
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Plasma HIV-1 RNA by SCA
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA
Időkeret: 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).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Measurement of CD4+ T-cell Counts
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in CD4+ T-cell Counts
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 RNA Levels
Időkeret: weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44
HIV-1 RNA levels by conventional assay
weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44
Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
Időkeret: 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)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
Időkeret: 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).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %CD69+ CD4+ T-cells
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %CD69+ CD4+ T-cells
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %CD69+ CD8+ T-cells
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %CD69+ CD8+ T-cells
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %Ki67+ CD4+ T-cells
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %Ki67+ CD4+ T-cells
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %Ki67+ CD8+ T-cells
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %Ki67+ CD8+ T-cells
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %PD1+ CD4+ T-cells
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %PD1+ CD4+ T-cells
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %PD1+ CD8+ T-cells
Időkeret: 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).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %PD1+ CD8+ T-cells
Időkeret: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

AIDS Clinical Trials Group

Együttműködők

National Institute of Allergy and Infectious Diseases (NIAID)

Nyomozók

  • Tanulmányi szék: Timothy Henrich, MD, University of California, San Francisco
  • Tanulmányi szék: Priscilla Hsue, MD, University of California, San Francisco

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2015. december 21.

Elsődleges befejezés (Tényleges)

2017. november 2.

A tanulmány befejezése (Tényleges)

2018. február 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2015. április 6.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2015. május 8.

Első közzététel (Becslés)

2015. május 12.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2021. augusztus 3.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2021. július 30.

Utolsó ellenőrzés

2019. december 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • ACTG A5337
  • 2UM1AI068636 (Az Egyesült Államok NIH támogatása/szerződése)

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