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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02990312
Other study ID # HP-00072807
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date May 1, 2017
Est. completion date July 17, 2019

Study information

Verified date December 2019
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this proof of concept, pilot study is to determine whether the unique combination of the human immunodeficiency virus (HIV) co-receptor antagonist, Maraviroc, and the mammalian target of rapamycin (mTOR) inhibitor, Sirolimus, in HIV-infected kidney transplant recipients has an impact on chemokine receptor 5 (CCR5) density, the HIV-reservoir, or rejection of the transplanted kidney. 15 HIV-infected kidney transplant recipients will be recruited and their immunosuppressant regimen will be changed to include an mTOR inhibitor (such as Sirolimus) unless they are already on one. In addition, Maraviroc will be added to their HIV regimen, unless they are already on Maraviroc. Blood will be taken to measure markers of the HIV reservoir, their CCR5 density and expression, and immune activation.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sirolimus + Maraviroc
Patients will be placed on the combination of Sirolimus and Maraviroc starting on Day 0 and followed for 96 weeks during which they will have regular monitoring of both clinical safety labs, Sirolimus levels, and research labs to look at the HIV reservoir, CCR5 density, and immune activation

Locations

Country Name City State
United States Institute of human virology Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary HIV viral reservoir total cellular HIV DNA 96 weeks
Secondary Secondary measures of the HIV viral reservoir Chromosomal HIV DNA 96 weeks
Secondary Circulating HIV Ultrasensitive HIV RNA 96 weeks
Secondary CCR5 Receptor Density CCR5 receptor density 96 weeks
Secondary CCR5 Expression Percentage of T cells expressing CCR5 96 weeks
Secondary Acute cellular rejection Incidence of T cell mediated rejection (ACR) 96 weeks
Secondary Antibody mediated rejection Incidence of antibody mediated rejection (AMR) 96 weeks
Secondary Markers of immune activation/inflammation measured by Ki67 Measurement of Ki67 96 weeks
Secondary Markers of immune activation/inflammation measured by cluster of differentiation 38 (CD38) Measurement of CD38 96 weeks
Secondary Markers of immune activation/inflammation measured by human leukocyte antigen-antigen D Related (HLA DR) Measurement of HLA DR 96 weeks
Secondary Markers of immune activation/inflammation measured by programmed death 1 (PD-1) Measurement of PD-1 96 weeks
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