Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607588
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Selection of Resistant Mutations to Dolutegravir and Associated Drugs in PLWH Treated in Clinical Practice in Chokwé Mozambique
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDOCH
Brief Summary:
The HIV infection not fully controlled despite being under antiretroviral treatment could make virus resistance against the antiretroviral treatments making hardest the well control of HIV infection The purpose of this research study is to confirm or deny if a not fully good controlled HIV infection could develop virus resistance against antiretroviral drugs that can difficult the good control of the HIV infection
Detailed Description:
This research study consists of a single visit in which you will be taken an additional vial of blood to analyze the presence or absence of mutations in your virus to HIV drugs In addition other HIV infection routine information will be recorded
Demographic data
HIV infection history data
Virological failure information
Laboratory parameters Resistance tests techniques Genotyping resistance test will be performed from plasma samples in those patients with viral load over 200 copiesml using ultracentrifugation if needed Inzaule Seth C et al J Antimicrob Chemother 2018 Briefly RNA will be extracted and HIV-1 pol gene will be amplified followed by a nested-PCR Amplification products will be purified quantified and finally diluted and prepared for sequencing following Illumina DNA Sample Preparation Kit protocol Illumina San Diego CA Samples will finally be pooled and sequenced in a MiSeq System Illumina MiSeq sequences will be downloaded from Basespace Illumina and analysed using PASeq IrsiCaixaBarcelonaES v1418 httpswwwpaseqorg The questionnaire about clinical and demographic characteristics will be performed during the study visit
Demographic data
HIV infection history data
Virological failure information
Laboratory parameters Resistance tests techniques Genotyping resistance test will be performed from plasma samples in those patients with viral load over 200 copiesml using ultracentrifugation if needed Inzaule Seth C et al J Antimicrob Chemother 2018 Briefly RNA will be extracted and HIV-1 pol gene will be amplified followed by a nested-PCR Amplification products will be purified quantified and finally diluted and prepared for sequencing following Illumina DNA Sample Preparation Kit protocol Illumina San Diego CA Samples will finally be pooled and sequenced in a MiSeq System Illumina MiSeq sequences will be downloaded from Basespace Illumina and analysed using PASeq IrsiCaixaBarcelonaES v1418 httpswwwpaseqorg The questionnaire about clinical and demographic characteristics will be performed during the study visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None