N/A
N=62
LoViReT (Low Viral Reservoir Treated Patients)
Hiv
Bottom Line
View on ClinicalTrials.gov: NCT02972931 ↗Enrolled (actual)
62
Serious AEs
2.3%
Results posted
Sep 2024
Primary outcome: Primary: Longitudinal Analysis of Total HIV DNA and Immune-phenotype by Digital Droplet Polymerase Chain Reaction (PCR) and Flow Cytometry, Respectively, Comparing This Outcome Before and After cART (Evaluation of cART Effect on This Parameters) — 812; 5062; 54; 714 DNA copies/milion of CD4 T cells
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IrsiCaixa
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Longitudinal Analysis of Total HIV DNA and Immune-phenotype by Digital Droplet Polymerase Chain Reaction (PCR) and Flow Cytometry, Respectively, Comparing This Outcome Before and After cART (Evaluation of cART Effect on This Parameters) |
812; 5062; 54; 714 | — |
| PRIMARY Replication Competent Reservoir in Patients With Low (LoViReT) Normal (Controls) Levels of Total HIV DNA |
4; 10 | — |
| PRIMARY Evaluation and Comparison of CD8 T-cell Responses by Inhibition Assays, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA |
57.52; 50.17; 38.61; 42.77; 27.05; 57.33 | — |
| PRIMARY Analysis and Comparison of Progression-associated Genetic Factors, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA |
16; 11; 6; 3; 0; 0 | — |
| PRIMARY Measurement of Genotypic Tropism in Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA |
12; 18; 1; 3; 9; 1 | — |
Summary
The main purpose of this study is to unravel the mechanisms by which the "Low Viral Reservoir Treated" patients (LoViReT) maintain extremely low HIV-1 DNA levels despite having initiated cART during chronic HIV-1 infection. This group may have specific and different clinical, virological and immunogenetical characteristics, compared to patients with regular reservoir size, which might be useful to design new and more effective treatment approaches.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02972931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.