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

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

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-08

Study Completion Date

2020-03-05

Brief Summary

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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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Detailed Description

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Conditions

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HIV-1-infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Blood samples

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No