- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02440789
Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)
Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
-
-
California
-
San Francisco, California, Yhdysvallat, 94110
- 801 University of California, San Francisco HIV/AIDS CRS
-
-
District of Columbia
-
Washington, District of Columbia, Yhdysvallat, 20005
- Whitman Walker Health CRS (31791)
-
-
Florida
-
Miami, Florida, Yhdysvallat, 33136
- Univ. of Miami AIDS CRS (901)
-
-
Georgia
-
Atlanta, Georgia, Yhdysvallat, 30308
- The Ponce de Leon Center CRS (5802)
-
-
Missouri
-
Saint Louis, Missouri, Yhdysvallat, 63110
- Washington University CRS (2101)
-
-
New York
-
New York, New York, Yhdysvallat, 10011
- Weill Cornell Uptown CRS (7803)
-
Rochester, New York, Yhdysvallat, 14642
- 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS
-
-
Ohio
-
Cincinnati, Ohio, Yhdysvallat, 45267
- Univ. of Cincinnati CRS (2401)
-
-
Texas
-
Houston, Texas, Yhdysvallat, 77030
- Houston AIDS Research Team CRS (31473)
-
-
Washington
-
Seattle, Washington, Yhdysvallat, 98104
- University of Washington AIDS CRS (1401)
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Number of Participants Who Met the Study-defined Composite Safety Endpoint
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Measurement of CD4+ T-cell Counts
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Timothy Henrich, MD, University of California, San Francisco
- Opintojen puheenjohtaja: Priscilla Hsue, MD, University of California, San Francisco
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ACTG A5337
- 2UM1AI068636 (Yhdysvaltain NIH-apuraha/sopimus)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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Meril Life Sciences Pvt. Ltd.TuntematonSepelvaltimotautiYhdistynyt kuningaskunta, Brasilia, Espanja, Makedonia, entinen Jugoslavian tasavalta, Belgia, Tšekki, Latvia, Alankomaat, Puola
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Université Catholique de LouvainValmis
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Singapore General HospitalAktiivinen, ei rekrytointiÄäreisvaltimotauti | Kriittinen alaraajojen iskemiaSingapore
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Nemours Children's ClinicRekrytointiVerisuonten anomaliaYhdysvallat
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The University of Texas Health Science Center at...ValmisInvasive Bladder Cancer Stage IIYhdysvallat
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Fatebenefratelli and Ophthalmic HospitalValmisPerkutaaninen sepelvaltimointerventio | Angioplastia, ilmapallo, sepelvaltimot | Valtimotauti, sepelvaltimot | Sepelvaltimon angioplastia, transluminaalinen ilmapalloItalia