HivLoViReTNCT02972931

LoViReT (Low Viral Reservoir Treated Patients)

An observational study of Hiv, run by IrsiCaixa at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hiv
How many people: 62 participants
Where: 1 siteSpain
Study dates: 18 Jan 2018to 20 Jun 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: HIV-infected subjects with extremely low or undetectable HIV-1 DNA levels in peripheral blood despite having initiated cART during chronic HIV-1 infection

Who may be able to join

≥ 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

Who cannot join

cART discontinuation between previous screening and Visit #1.
HIV-RNA above 50 copies/mL between previous screening to Visit #1

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916

Other trials in Spain

About this study

Official title: Impact of Antiretroviral Treatment and Predictors in Subjects With Extremely Low HIV-1 Reservoir: Optimization of New Cure Strategies

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.

Read the detailed description

Combination antiretroviral therapy (cART) is highly successful suppressing HIV-1 replication and clinical progression in infected patients. However, it does not hamper the establishment of viral reservoirs, generating latently infected cells that provoke a quick rebound of HIV viremia after treatment interruption. Different strategies to tackle HIV-1 reservoirs have been suggested during last years with limited success. Actually, the few cases of described HIV-1 functional cure are found in elite and post-treatment controllers. Thus, some patients with regular HIV progression can control replication spontaneously, most of them after receiving cART during primary HIV-1 infection. Indeed, the "Mississippi baby", who was treated 36h after birth, had sustained undetectable viremia for 27 months after treatment interruption. Recently, it has also been proven in successfully treated patients that low proviral reservoir is related to better HIV-1 control after treatment discontinuation. Thus, the identification of patients with lower latent reservoir in chronic infection will allow unveiling potential mechanisms to achieve a functional cure after cART withdrawal.

Our center in Badalona allocates a biological sample collection containing 72,000 specimens from HIV-1-infected subjects. Samples from 319 patients under suppressive cART for more than 3 years have been screened using the high sensitive BioRad droplet digital Polymerase Chain Reaction platform (ddPCR). Among the screened patients, a cohort of 20 "Low Viral Reservoir Treated" patients (LoViReT) with extremely low or undetectable HIV-1 DNA levels in peripheral blood despite having initiated cART during chronic HIV-1 infection have been established, which is expected to be increased up to 40 patients. Discovering the factors that reduce HIV reservoir and make LoViReT patients maintain extremely low levels of proviral HIV-1 DNA will open new treatment strategies based on maintaining the reservoir to the lowest levels beside the regular clinical marker of viral load. In addition, a further second step of controlled cART interruption can be designed to evaluate the real impact of harboring extremely low levels of latent reservoir for further functional HIV cure.

To unravel the mechanisms by which the LoViReT cohort maintain extremely low HIV-1 DNA levels despite having initiated cART during chronic HIV-1 infection, this cohort will be studied from different points of view. All the results will be compared to a control group of 40 individuals with standard levels of total HIV DNA (reservoir). Three mayor aims will be addressed to then extrapolate our results to larger chronic HIV-1-infected populations:

To investigate the role of cART on the suppression of the HIV reservoir in the LoViReT patients, compared to controls. 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.
To investigate the integrity of HIV sequences in the LoViReT patients and its relationship with pathogenesis, in comparison to controls. Genotypic HIV tropism and the full viral genome will be analyzed through sequencing from DNA of patients' Peripheral Blood Mononuclear Cells (PBMC). Fresh blood samples will be taken from the 40 LoViReT and 40 control patients in the study. In addition, for those exerting virus production, viral isolates will be used to analyze viral replication capacity and cell pathogenesis.
To investigate the role of immune-genetic factors that along with cART contribute to reduce the HIV reservoirs in the LoViReT patients. Functional T-cell response will be measured isolating CD8 T cells and measuring the inhibition capacity for HIV replication in each patient. Specific HIV-related CD8 T-cell interferon production will be also evaluated under epitope stimulus. Other progression associated genetic factors as Human Leukocyte Antigen (HLA) type, and chemokine receptor 5 (CCR5) and 2 (CCR2), and SIGLEC-1 Single Nucleotide Polymorphisms (SNPs) will be also explored.

Conditions: Hiv
Keywords: HIV infection, low HIV reservoir, functional cure
Medical subject headings: Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02972931
Study group	Role	What they receive
LoViReT		HIV-infected subjects with extremely low or undetectable HIV-1 DNA levels in peripheral blood despite having initiated cART during chronic HIV-1 infection
Standard Reservoir Level		HIV-infected subjects who initiated cART during chronic HIV-1 infection and that show standard HIV-1 DNA levels in peripheral blood

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
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.
Measured: The time frame for the outcome measure is an average of 5 years. Including a baseline, 18 months, and 5 years post cART initiation.
Replication Competent Reservoir in Patients With Low (LoViReT) Normal (Controls) Levels of Total HIV DNA
Replication competent reservoir will be analyzed with the gold standard quantitative viral outgrowth assay (qVOA).
Measured: The time frame for the outcome measure is on patients on cART for at least 5 years.
Evaluation and Comparison of CD8 T-cell Responses by Inhibition Assays, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA
Functional T-cell response will be measured isolating CD8 T and Nk cells and measuring the inhibition capacity for HIV replication in each patient.
Measured: The time frame for the outcome measure is on samples before initiation of cART and after 5 years on cART
Analysis and Comparison of Progression-associated Genetic Factors, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA
Different progression-associated genetic factors, such as HLA type, and CCR5, CCR2 and SIGLEC-1 single nucleotide polymorphisms (SNPs) will be also explored.
Measured: The time frame for the outcome measure is on patients on cART for at least 5 years.
Measurement of Genotypic Tropism in Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA
Genotypic HIV tropism and the full viral genome will be analyzed through sequencing from DNA of patients' peripheral blood mononuclear cells (PBMC).
Measured: The time frame for the outcome measure is on patients on cART for at least 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 201820 Jun 2019

First posted25 Nov 2016 (estimated)
Study start18 Jan 2018
Primary completion20 Jun 2019
Study completion20 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02972931
Sponsor's protocol ID: LoViReT
Acronym: LoViReT
Status last verified: Oct 2020
First submitted: 17 Nov 2016
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Galvez C, Urrea V, Dalmau J, Jimenez M, Clotet B, Monceaux V, Huot N, Leal L, Gonzalez-Soler V, Gonzalez-Cao M, Muller-Trutwin M, Saez-Cirion A, Garcia F, Blanco J, Martinez-Picado J, Salgado M. Extremely low viral reservoir in treated chronically HIV-1-infected individuals. EBioMedicine. 2020 Jul;57:102830. doi: 10.1016/j.ebiom.2020.102830. Epub 2020 Jun 21.
PubMed 32580136
Galvez C, Urrea V, Garcia-Guerrero MDC, Bernal S, Benet S, Mothe B, Bailon L, Dalmau J, Martinez A, Nieto A, Leal L, Garcia F, Clotet B, Martinez-Picado J, Salgado M. Altered T-cell subset distribution in the viral reservoir in HIV-1-infected individuals with extremely low proviral DNA (LoViReTs). J Intern Med. 2022 Aug;292(2):308-320. doi: 10.1111/joim.13484. Epub 2022 Mar 28.
PubMed 35342993

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Antiretroviral Treatment and Predictors in Subjects With Extremely Low HIV-1 Reservoir: Optimization of New Cure Strategies
ClinicalTrials.gov ID: NCT02972931
Acronym / sponsor ID: LoViReT / LoViReT
Conditions: Hiv
Keywords: HIV infection, low HIV reservoir, functional cure
Study type: Observational
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: IrsiCaixaUniversity, hospital or other
Study start: 18 Jan 2018 (actual)
Primary completion: 20 Jun 2019 (actual)
Study completion: 20 Jun 2019 (actual)
First posted: 25 Nov 2016 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To investigate the role of cART on the suppression of the HIV reservoir in the LoViReT patients, compared to controls. 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.
To investigate the integrity of HIV sequences in the LoViReT patients and its relationship with pathogenesis, in comparison to controls. Genotypic HIV tropism and the full viral genome will be analyzed through sequencing from DNA of patients' Peripheral Blood Mononuclear Cells (PBMC). Fresh blood samples will be taken from the 40 LoViReT and 40 control patients in the study. In addition, for those exerting virus production, viral isolates will be used to analyze viral replication capacity and cell pathogenesis.
To investigate the role of immune-genetic factors that along with cART contribute to reduce the HIV reservoirs in the LoViReT patients. Functional T-cell response will be measured isolating CD8 T cells and measuring the inhibition capacity for HIV replication in each patient. Specific HIV-related CD8 T-cell interferon production will be also evaluated under epitope stimulus. Other progression associated genetic factors as Human Leukocyte Antigen (HLA) type, and chemokine receptor 5 (CCR5) and 2 (CCR2), and SIGLEC-1 Single Nucleotide Polymorphisms (SNPs) will be also explored.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
LoViReT	–	–HIV-infected subjects with extremely low or undetectable HIV-1 DNA levels in peripheral blood despite having initiated cART during chronic HIV-1 infection
Standard Reservoir Level	–	–HIV-infected subjects who initiated cART during chronic HIV-1 infection and that show standard HIV-1 DNA levels in peripheral blood

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HIV-infected subjects with extremely low or undetectable HIV-1 DNA levels in peripheral blood despite having initiated cART during chronic HIV-1 infection

Key inclusion criteria (6 listed)

≥ 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

Key exclusion criteria (2 listed)

cART discontinuation between previous screening and Visit #1.
HIV-RNA above 50 copies/mL between previous screening to Visit #1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)
Time frame: 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.
Replication Competent Reservoir in Patients With Low (LoViReT) Normal (Controls) Levels of Total HIV DNA
Time frame: 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).
Evaluation and Comparison of CD8 T-cell Responses by Inhibition Assays, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA
Time frame: 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.
Analysis and Comparison of Progression-associated Genetic Factors, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA
Time frame: 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.
Measurement of Genotypic Tropism in Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA
Time frame: 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).

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LoViReT	30	22
Standard Reservoir Level	32	22

Primary outcome: 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)

Time frame: The time frame for the outcome measure is an average of 5 years. Including a baseline, 18 months, and 5 years post cART initiation.. Median (Inter-Quartile Range). Unit: DNA copies/milion of CD4 T cells

Measure	LoViReT n = 12	Standard Reservoir Level n = 13
Baseline	812 (485 to 1392)	5062 (2649 to 8943)
Last sample	54 (38 to 67)	714 (517 to 1462)

Population analysed: The participants analyzed correspond to a subgroup of participants with sample availability for all the timepoints analyzed, and started cART during chronic HIV-1 infection.

Primary outcome: Replication Competent Reservoir in Patients With Low (LoViReT) Normal (Controls) Levels of Total HIV DNA

Time frame: The time frame for the outcome measure is on patients on cART for at least 5 years.. Count of participants. Unit: Participants

Measure	Loviret n = 14
Positive	4
Negative	10

Population analysed: The participants analyzed correspond to a subgroup LoVireT who agreed to have a phlebotomy. No results for control group because de phlebotomy was not indicated.

Primary outcome: Evaluation and Comparison of CD8 T-cell Responses by Inhibition Assays, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA

Time frame: The time frame for the outcome measure is on samples before initiation of cART and after 5 years on cART. Median (Inter-Quartile Range). Unit: percentage of inhibition

Measure	LoViReT n = 11	Standard Reservoir Level n = 11
NK cells pre cART	57.52 (14.54 to 77.36)	50.17 (10.56 to 69.53)
NK cells 5 years on cART	38.61 (5.71 to 54.2)	42.77 (0.88 to 63.51)
CD8 T cells pre cART	27.05 (0 to 39.37)	57.33 (52.77 to 81.36)
CD8 T cells 5 years on cART	28.09 (0 to 57.05)	41.21 (0 to 76.25)

Population analysed: 11 LoViReT and 11 controls with available samples before initiation of cART and after 5 years on cART were analyzed

Primary outcome: Analysis and Comparison of Progression-associated Genetic Factors, Between Patients With Low (LoViReT) and Normal (Controls) Levels of Total HIV DNA

Time frame: The time frame for the outcome measure is on patients on cART for at least 5 years.. Count of participants. Unit: Participants

Measure	LoViReT n = 22	Standard Reservoir Level n = 22
CCR5 genotype: wild type homozygous	16	11
CCR5 genotype: heterozygous	6	3
CCR5 genotype: mutated homozygous	0	0
CCR5 genotype: Not available	0	8
Siglec-1 genotype: wild type homozygous	21	21
Siglec-1 genotype: heterozygous	1	1
Siglec-1 genotype: mutated homozygous	0	0
Siglec-1 genotype: Not available	0	0

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LoViReT	1 of 22 (4.5%)	4 of 22 (18.2%)	0 of 22
Standard Reservoir Level	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): As expected and included in the protocol, not all participants were willing to provide all the types of samples, but relevant results were obtained anyway.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32580136Galvez C, Urrea V, Dalmau J, Jimenez M, Clotet B, Monceaux V, Huot N, Leal L, Gonzalez-Soler V, Gonzalez-Cao M, Muller-Trutwin M, Saez-Cirion A, Garcia F, Blanco J, Martinez-Picado J, Salgado M. Extremely low viral reservoir in treated chronically HIV-1-infected individuals. EBioMedicine. 2020 Jul;57:102830. doi: 10.1016/j.ebiom.2020.102830. Epub 2020 Jun 21.
Background: PubMed 35342993Galvez C, Urrea V, Garcia-Guerrero MDC, Bernal S, Benet S, Mothe B, Bailon L, Dalmau J, Martinez A, Nieto A, Leal L, Garcia F, Clotet B, Martinez-Picado J, Salgado M. Altered T-cell subset distribution in the viral reservoir in HIV-1-infected individuals with extremely low proviral DNA (LoViReTs). J Intern Med. 2022 Aug;292(2):308-320. doi: 10.1111/joim.13484. Epub 2022 Mar 28.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier Martinez-Picado, PhD principal investigator

IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hiv, run by IrsiCaixa at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: The time frame for the outcome measure is an average of 5 years. Including a baseline, 18 months, and 5 years post cART initiation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02972931, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.