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

30. juli 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

32

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sirolimus
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Who Met the Study-defined Composite Safety Endpoint
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Measurement of CD4+ T-cell Counts
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AIDS Clinical Trials Group

Samarbeidspartnere

National Institute of Allergy and Infectious Diseases (NIAID)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. desember 2015

Primær fullføring (Faktiske)

2. november 2017

Studiet fullført (Faktiske)

1. februar 2018

Datoer for studieregistrering

Først innsendt

6. april 2015

Først innsendt som oppfylte QC-kriteriene

8. mai 2015

Først lagt ut (Anslag)

12. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2021

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACTG A5337
  • 2UM1AI068636 (U.S. NIH-stipend/kontrakt)

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