NCT02972931: LoViReT

LoViReT (Low Viral Reservoir Treated Patients)

Completed Results posted Last updated 19 September 2024

What this trial tests

trial in Hiv in 62 participants. Completed in 20 June 2019.

Timeline

18 January 2018

Primary endpoint
20 June 2019

20 June 2019

Quick facts

Lead sponsor	IrsiCaixa
Status	Completed
Study type	OBSERVATIONAL
Enrollment	62
Start date	18 January 2018
Primary completion	20 June 2019
Estimated completion	20 June 2019
Sites	1 location across Spain

Conditions studied

• Hiv — all drugs for Hiv →

Sponsor

IrsiCaixa — full company profile →

Who can join

18 and older, any sex, with Hiv. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · The time frame for the outcome measure is an average of 5 years. Including a baseline, 18 months, and 5 years post cART initiation.

To address this objective, a longitudinal analysis of proviral HIV DNA for each patient will be performed, including time points previous to cART. In total, 200 samples will be analyzed and dynamic models will be built for the two different levels of reservoir establishment. General immune phenotype of cellular populations, including also activation markers, will be also assessed in all time points.

Baseline

Group	Value	95% CI
LoViReT	812	485 – 1392
Standard Reservoir Level	5062	2649 – 8943

Last sample

Group	Value	95% CI
LoViReT	54	38 – 67
Standard Reservoir Level	714	517 – 1462

Replication Competent Reservoir in Patients With Low (LoViReT) Normal (Controls) Levels of Total HIV DNA Primary · The time frame for the outcome measure is on patients on cART for at least 5 years.

Replication competent reservoir will be analyzed with the gold standard quantitative viral outgrowth assay (qVOA).

Group	Value	95% CI
Loviret	4
Loviret	10

Evaluation and Comparison of CD8 T-cell Responses by Inhibition Assays, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA Primary · The time frame for the outcome measure is on samples before initiation of cART and after 5 years on cART

Functional T-cell response will be measured isolating CD8 T and Nk cells and measuring the inhibition capacity for HIV replication in each patient.

NK cells pre cART

Group	Value	95% CI
LoViReT	57.52	14.54 – 77.36
Standard Reservoir Level	50.17	10.56 – 69.53

NK cells 5 years on cART

Group	Value	95% CI
LoViReT	38.61	5.71 – 54.2
Standard Reservoir Level	42.77	0.88 – 63.51

CD8 T cells pre cART

Group	Value	95% CI
LoViReT	27.05	0 – 39.37
Standard Reservoir Level	57.33	52.77 – 81.36

CD8 T cells 5 years on cART

Group	Value	95% CI
LoViReT	28.09	0 – 57.05
Standard Reservoir Level	41.21	0 – 76.25

Analysis and Comparison of Progression-associated Genetic Factors, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA Primary · The time frame for the outcome measure is on patients on cART for at least 5 years.

Different progression-associated genetic factors, such as HLA type, and CCR5, CCR2 and SIGLEC-1 single nucleotide polymorphisms (SNPs) will be also explored.

CCR5 genotype

Group	Value	95% CI
LoViReT	16
Standard Reservoir Level	11
LoViReT	6
Standard Reservoir Level	3
LoViReT	0
Standard Reservoir Level	0
LoViReT	0
Standard Reservoir Level	8

Siglec-1 genotype

Group	Value	95% CI
LoViReT	21
Standard Reservoir Level	21
LoViReT	1
Standard Reservoir Level	1
LoViReT	0
Standard Reservoir Level	0
LoViReT	0
Standard Reservoir Level	0

Measurement of Genotypic Tropism in Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA Primary · The time frame for the outcome measure is on patients on cART for at least 5 years.

Genotypic HIV tropism and the full viral genome will be analyzed through sequencing from DNA of patients' peripheral blood mononuclear cells (PBMC).

CCR5

Group	Value	95% CI
Loviret	12
Control	18

CXCR4

Group	Value	95% CI
Loviret	1
Control	3

Not determined

Group	Value	95% CI
Loviret	9
Control	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LoViReT

Serious: 1/22 (5%)

Deaths: 0/22

Standard Reservoir Level

Serious: 0/22 (0%)

Deaths: 0/22

Serious adverse events (1 terms)

Reaction	System	LoViReT	Standard Reservoir Level
Saddle dermatoma	Nervous system disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	LoViReT	Standard Reservoir Level
Swelling	General disorders	—	—
Acute bronchitis	Infections and infestations	—	—

Most-reported serious reactions: Saddle dermatoma.

Data from ClinicalTrials.gov NCT02972931 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.