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

30. Juli 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

32

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Sirolimus
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Met the Study-defined Composite Safety Endpoint
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Measurement of CD4+ T-cell Counts
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AIDS Clinical Trials Group

Mitarbeiter

National Institute of Allergy and Infectious Diseases (NIAID)

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. Dezember 2015

Primärer Abschluss (Tatsächlich)

2. November 2017

Studienabschluss (Tatsächlich)

1. Februar 2018

Studienanmeldedaten

Zuerst eingereicht

6. April 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2015

Zuerst gepostet (Schätzen)

12. Mai 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. August 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juli 2021

Zuletzt verifiziert

1. Dezember 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ACTG A5337
  • 2UM1AI068636 (US NIH Stipendium/Vertrag)

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