Dynamics of Drug Resistance-associated Mutations in HIV-1 DNA Reverse Transcriptase Clearance During Effective Antiretroviral Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-07-01

Brief Summary

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In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization.

Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for an unknown duration and reemerge in case of therapeutic selective pressure.

There is a need to assess the dynamic of archived Drug resistance associated mutations (DRAMs) clearance in cell-associated HIV DNA after a long period of virological control, in the perspective of ARVs recycling.

The investigators postulate that it could be interesting in the future to recycle ARV drugs (that where classified as "resistant" in the past) in subsequent regimen. The question is particularly important for 3TC/FTC for subsequent new regimen and for the use of dual regimen (disappearance of M184V).

Thus, the investigators propose a retrospective, longitudinal analysis on blood-cell-associated HIV-1 DNA samples in order to investigate by Sanger and Ultra Deep Sequencing the dynamics of decay and persistence of DNA HIV-1 variants harboring key drug resistance-associated mutations to NRTIs, in particular M184V, in patients with sustained virological control for at least 5 years under effective ART.

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Detailed Description

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Conditions

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HIV-1-infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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5 years of virological suppression

\- Patients harboring a fully suppressed HIV-1 plasma viral load for at least 5 years

Genotypic Resistance Test

Intervention Type DIAGNOSTIC_TEST

A Genotypic Resistance Test by Sanger sequencing will be done after the period of virological suppression.

* If M184V is still present no additional test will be performed.
* If M184V is absent, we will go back in the previous samples (one per year) to determine the time point where the mutation has been cleared by sanger and UDS sequencing.

10 years of virological suppression

\- Patients harboring a fully suppressed HIV-1 plasma viral load for at least 10 years

Genotypic Resistance Test

Intervention Type DIAGNOSTIC_TEST

A Genotypic Resistance Test by Sanger sequencing will be done after the period of virological suppression.

* If M184V is still present no additional test will be performed.
* If M184V is absent, we will go back in the previous samples (one per year) to determine the time point where the mutation has been cleared by sanger and UDS sequencing.

Interventions

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Genotypic Resistance Test

A Genotypic Resistance Test by Sanger sequencing will be done after the period of virological suppression.

* If M184V is still present no additional test will be performed.
* If M184V is absent, we will go back in the previous samples (one per year) to determine the time point where the mutation has been cleared by sanger and UDS sequencing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infected
* Age ≥ 18 years
* Genotypic resistance test performed at time of failure and harboring at least M184V
* Fully suppressed HIV viral load for at least 5 or 10 years.
* Triple therapy or 2 drug regimen during the entire follow-up
* Availability of at least 1 stored whole blood sample /year