Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01378910
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2011-06-17
Brief Title:
Genotypic Tropism Testing In Proviral Dna To Guide CCR5 Antagonist Treatment In Subjects With Undetectable HIV-1 Viremia
Sponsor:
Fundación FLS de Lucha Contra el Sida las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Organization:
Fundación FLS de Lucha Contra el Sida las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study Overview
Official Title:
Use Of Genotypic HIV-1 Tropism Testing In Proviral DNA To Guide CCR5 Antagonist Treatment In Subjects With Undetectable HIV-1 Viremia
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity The assessment of HIV-1 tropism in proviral DNA could be helpful to inform in which of these subjects CCR5 antagonists could be efficacious
Detailed Description:
The assessment of HIV-1 tropism is needed before starting treatment with a CCR5-antagonist Several phenotypic and genotyping tropism tests have been developed in the recent years Phenotypic assays ie TrofileTM and ES-TrofileTM have been usedin most clinical trials Genotypic tropism testing however is easier cheaper and faster than phenotypic methods and can be performed in a local HIV laboratories
Viral RNA amplification is difficult in subjects with HIV-1 RNA levels 500-1000 copiesmL In these cases the optimal source of genetic material is peripheral blood mononuclear cell PBMC-associated proviral DNA Whereas genotypic tropism testing in proviral DNA is technically feasible it has not been validated as a tool to predict sustained virological response to CCR5-antagonist therapy in subjects with undetectable viremia
As of today maraviroc is the only CCR5-antagonist approved for HIV treatment It has few drug interactions and a good security profile particularly in terms of lipid and glucose metabolism Therefore it might be an adequate alternative for HIV-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity or metabolic problems
This study will evaluate 48-week virological outcomes in aviremic subjects with an R5 virus by proviral genotypic tropism testing who switch the third drug of their regimen to maraviroc
Viral RNA amplification is difficult in subjects with HIV-1 RNA levels 500-1000 copiesmL In these cases the optimal source of genetic material is peripheral blood mononuclear cell PBMC-associated proviral DNA Whereas genotypic tropism testing in proviral DNA is technically feasible it has not been validated as a tool to predict sustained virological response to CCR5-antagonist therapy in subjects with undetectable viremia
As of today maraviroc is the only CCR5-antagonist approved for HIV treatment It has few drug interactions and a good security profile particularly in terms of lipid and glucose metabolism Therefore it might be an adequate alternative for HIV-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity or metabolic problems
This study will evaluate 48-week virological outcomes in aviremic subjects with an R5 virus by proviral genotypic tropism testing who switch the third drug of their regimen to maraviroc
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