Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations

The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures.

This study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient who has given consent
Adult patient
Patient living with HIV-1
Controlled viral load (<50 RNA copies/ml) for at least 1 year.
At least two previous virologic failures, either :

Initial failure : defined as the persistence of a viral load greater than 50 copies/ml beyond 1 year, after the initiation of triple antiretroviral therapy, and without virological control (VL > 50 copies/ml) since the initiation of the very first antiretroviral treatment.
A rebound in HIV viral load to more than 50 copies/ml after a period of virological success, confirmed on two consecutive samples at least one month apart.
At least 2 Sanger RNA genotypes have been done or could be done from the existing library.

Exclusion criteria

Patient not affiliated to a medical insurance scheme
Protected adult
Pregnant, parturient or breastfeeding woman
Discontinuation of clinical and immuno-virological follow-up for more than 2 years

Treatment and study plan

blood samples

Biological

An additional blood tube will be taken during the patient's follow-up blood collection.

Primary outcomes

> Genotyping Score (GSS) comparison between HIV DNA-UDS genotyping assay obtained at inclusion and cumulative RNA-Sanger genotyping assays obtained at each virological failure during routine follow

Time frame: baseline

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: Mutapro

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: May 1, 2018
Registry last updated: Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed