Ignite Creation Date:
2024-05-06 @ 12:47 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03842488
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2018-12-19
Brief Title:
Raltegravir One Thousand Two Hundred vs Darunavir-cb in Immnunosupressed Patients ROTDIP Study
Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Organization:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study Overview
Official Title:
Multicenter Open Pilot Clinical Trial Aimed to Compare the Efficacy of RAL1200 QD vs DRV-cb 800-150 QD Both in Combination With TAFFTC in Patients With HIV Infection and CD4 Count Under 200 CellsmicroL
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
NOT_YET_RECRUITING
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:
ROTDIP
Brief Summary:
Multicenter randomized open label pilot clinical trial with two parallel arms aimed to compare the efficacy of Raltegravir RAL 1200mg QD vs DarunavirCobicistat DRV-cb 800-150mg QD both in combination with alafenamideemtricitabine TAFFTC in patients with Human Inmunodefficiency Virus HIV infection and CD4200 cellsmicroL
Detailed Description:
The trial consists of two parallel arms to study the therapeutic success of 48 weeks tolerability immunological recovery persistence of treatment safety and results reported by the subject in severely immunocompromised HIV infected patients with an initial CD4 count 200 cellsμl naive to antiretroviral therapy
Included subjects will be randomized two to one 21 to RAL 1200mg QD plus FTCTAF or DRVcb 800-150mg plus FTCTAF
Included subjects will be randomized two to one 21 to RAL 1200mg QD plus FTCTAF or DRVcb 800-150mg plus FTCTAF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None