Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03577782
Status:
UNKNOWN
Last Update Posted:
2018-07-05
First Post:
2018-06-12
Brief Title:
Vedolizumab Treatment in HIV-Infected Subjects Without Previous Antiretroviral Therapy
Sponsor:
Hospitales Universitarios Virgen del Rocío
Organization:
Hospitales Universitarios Virgen del Rocío
Study Overview
Official Title:
Phase II Clinical Trial to Analyze the Safety and Efficacy of Vedolizumab Combined With Antiretroviral Therapy to Achieve Permanent Virological Remission in HIV-infected Subjects Without Previous Antiretroviral Therapy
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
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:
None
Brief Summary:
HIV cannot be eliminated and remains in the body despite the treatment that is used for HIV-infection called antiretroviral treatment ART Individuals undergoing ART interruption rapidly experience virus rebound in the blood The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the elimination of the virus in blood in the absence of ART New drugs associated to ART that allow the elimination of the virus in the blood after ART withdrawn are needed In monkeys infected with SIV the analog of HIV the virus has disappeared from the blood after administration of a compound and cessation of ART There is an equivalent compound in humans called Vedolizumab The aim of the present study is to research if Vedolizumab combined with ART in subjects without previous ART is able to eliminate the virus from the blood after ART is not taken
Detailed Description:
HIV cannot be eradicated and keep latent in anatomical and cellular reservoirs In fact patients undergoing antiretroviral treatment ART interruption rapidly experience plasma viral load rebound The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the eradication or permanent remission of plasma viral load also known as functional cure in the absence of ART as occurs in persistent HIV controllers In this scenario new drugs associated to ART that allow the achievement of permanent plasma viral remission after ART withdrawn are needed
The main targets of HIV infection are the memory CD4 T-cells This cell subset is mainly located in gut associated lymphoid tissue GALT These lymphocytes are recruited to the gut thanks to the expression of the integrin α4β7 The Env protein gp120 binds to α4β7 and enable the dissemination of HIV in the gut At the same time the envelope of HIV is enriched in α4β7 coming from the plasma membrane of the host cells favoring its pathogenicity Recently the administration of a monoclonal antibody against α4β7 was shown to achieve significant protection for HIV transmission before and after low dose intravaginal inoculation of SIV in Rhesus Macaques Surprisingly long-term virological protection has been documented in SIV-infected macaques after ART interruption after administration and withdrawal of the monoclonal antibody against α4β7 The mechanisms through which this antibody has achieved the permanent remission of plasma viral load are not fully understood The success of these findings in the simian model makes the antibody against α4β7 a good candidate as ART adjuvant with the aim to reach a functional cure andor persistent virological remission in humans Currently there is a monoclonal antibody against α4β7 with known safety and security profiles in humans this antibody is commercially available under the name of Vedolizumab This antibody is used for the treatment of ulcerative colitis and Crohn Disease In fact there are already two clinical trials that are using Vedolizumab in HIV-infected patients NCT02788175 y NCT03147859 In these clinical trials Vedolizumab is administered in the chronic phase of the infection in subjects with undetectable viral load during at least two years on ART There are not clinical trials administering Vedolizumab in early stages of infection in naïve HIV-infected subjects for ART Potentially this strategy of early antibody treatment may increase the success of the therapy and decrease the time on ART of the individuals The aim of the present clinical trial is to evaluate the safety and efficacy of Vedolizumab combined with ART to achieve permanent virological remission in naïve HIV-infected individuals after ART interruption
The main targets of HIV infection are the memory CD4 T-cells This cell subset is mainly located in gut associated lymphoid tissue GALT These lymphocytes are recruited to the gut thanks to the expression of the integrin α4β7 The Env protein gp120 binds to α4β7 and enable the dissemination of HIV in the gut At the same time the envelope of HIV is enriched in α4β7 coming from the plasma membrane of the host cells favoring its pathogenicity Recently the administration of a monoclonal antibody against α4β7 was shown to achieve significant protection for HIV transmission before and after low dose intravaginal inoculation of SIV in Rhesus Macaques Surprisingly long-term virological protection has been documented in SIV-infected macaques after ART interruption after administration and withdrawal of the monoclonal antibody against α4β7 The mechanisms through which this antibody has achieved the permanent remission of plasma viral load are not fully understood The success of these findings in the simian model makes the antibody against α4β7 a good candidate as ART adjuvant with the aim to reach a functional cure andor persistent virological remission in humans Currently there is a monoclonal antibody against α4β7 with known safety and security profiles in humans this antibody is commercially available under the name of Vedolizumab This antibody is used for the treatment of ulcerative colitis and Crohn Disease In fact there are already two clinical trials that are using Vedolizumab in HIV-infected patients NCT02788175 y NCT03147859 In these clinical trials Vedolizumab is administered in the chronic phase of the infection in subjects with undetectable viral load during at least two years on ART There are not clinical trials administering Vedolizumab in early stages of infection in naïve HIV-infected subjects for ART Potentially this strategy of early antibody treatment may increase the success of the therapy and decrease the time on ART of the individuals The aim of the present clinical trial is to evaluate the safety and efficacy of Vedolizumab combined with ART to achieve permanent virological remission in naïve HIV-infected individuals after ART interruption
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000497-30 | EUDRACT_NUMBER | None | None |