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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02972931 |
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Date of registration:
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17/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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LoViReT (Low Viral Reservoir Treated Patients)
LoViReT |
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Scientific title:
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Impact of Antiretroviral Treatment and Predictors in Subjects With Extremely Low HIV-1 Reservoir: Optimization of New Cure Strategies |
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Date of first enrolment:
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January 18, 2018 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02972931 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Javier Martinez-Picado, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- = 18 years of age
- Voluntarily signed informed consent
- Proven HIV-1 infection
- On stable cART regimen (antiretroviral therapy consisting of at least 3 registered
antiretroviral agents) for at least 3 years
- HIV-RNA <50 copies/mL during the last 3 years prior to the study
- Proviral HIV-DNA <50 copies/million PBMCs by using the ultrasensitive BioRad residual
ddPCR quantification platform
Exclusion Criteria:
- cART discontinuation between previous screening and Visit #1.
- HIV-RNA above 50 copies/mL between previous screening to Visit #1
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hiv
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Primary Outcome(s)
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Comparison of integrity and functionality of HIV sequences, through full viral genome sequencing, genotypic tropism and qVOA, between patients with Low (LoViReT) and Normal (controls) levels of total HIV DNA
[Time Frame: 16 months]
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Longitudinal analysis of total HIV DNA and immune-phenotype by Digital Droplet PCR and Flow Cytometry, respectively, comparing this outcome before and after cART (evaluation of cART effect on this parameters)
[Time Frame: 10 months]
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Analysis and comparison of progression-associated genetic factors, between patients with Low (LoViReT) and Normal (controls) levels of total HIV DNA
[Time Frame: 4 months]
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Evaluation and Comparison of CD8 T-cell responses, by ELISPOT and inhibition assays, between patients with Low (LoViReT) and Normal (controls) levels of total HIV DNA
[Time Frame: 8 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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