Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485154
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-10
Brief Title:
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
Sponsor:
University of Witwatersrand South Africa
Organization:
University of Witwatersrand South Africa
Study Overview
Official Title:
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
PICASSO
Brief Summary:
This is a single-arm open-label effectiveness study designed to evaluate the use of Tenofovir Lamivudine and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months Participants will be followed up for a period of 12 months from enrolment
Detailed Description:
Study participants are HIV-1 infected adult patients recruited A target of 100 participants will be enrolled and started on Tenofovir Lamivudine and Dolutegravir at enrolment Clinical assessments for these participants will be conducted throughout the study as per the Schedule of Events
This will be a two-phase interventional study to identify the optimally safe and effective Antiretroviral Therapy regimen for individuals with newly detected Human Immunodeficiency Virus infection after Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure In the Initial Phase the investigator will demonstrate proof of principle for the use of standardized Antiretroviral Therapy regimens in combination with pre-treatment genotypic drug resistance testing to achieve virologic suppression in individuals with prior Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure and understand drug resistance patterns prior to Antiretroviral Therapy initiation To do this the investigator will use a single-arm interventional design using Tenofovir Lamivudine and dolutegravir This supports programmatic rollout particularly in developing countries where baseline Human Immunodeficiency Virus genotyping is not performed prior to initiation of Antiretroviral Therapy The over-arching goals of Phase I are to determine the feasibility of our study design to recruit people with detectable Human Immunodeficiency Virus after prior use of Cabotegravir-Long-acting Pre-Exposure Prophylaxis failure and to estimate virologic suppression rates with current first-line standard of care Tenofovir Lamivudine and Dolutegravir therapy
At the conclusion of the Initial Phase data will be assessed to determine the need for and optimal design of a potential Second Phase the details of which will not be described in this protocol Should the investigator find sub-optimal virologic suppression rates on Tenofovir Lamivudine and Dolutegravir regimens in this trial the investigator would then proceed to the Second Phase in which the investigator will compare DarunavirRitonavir based Antiretroviral Therapy with Tenofovir Lamivudine and Dolutegravir in an open-label randomized non-inferiority clinical trial The aim of the second phase will be to determine whether an alternative to the predominant first-line regimen in much of the world will be required to optimise virologic suppression for this population
This will be a two-phase interventional study to identify the optimally safe and effective Antiretroviral Therapy regimen for individuals with newly detected Human Immunodeficiency Virus infection after Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure In the Initial Phase the investigator will demonstrate proof of principle for the use of standardized Antiretroviral Therapy regimens in combination with pre-treatment genotypic drug resistance testing to achieve virologic suppression in individuals with prior Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure and understand drug resistance patterns prior to Antiretroviral Therapy initiation To do this the investigator will use a single-arm interventional design using Tenofovir Lamivudine and dolutegravir This supports programmatic rollout particularly in developing countries where baseline Human Immunodeficiency Virus genotyping is not performed prior to initiation of Antiretroviral Therapy The over-arching goals of Phase I are to determine the feasibility of our study design to recruit people with detectable Human Immunodeficiency Virus after prior use of Cabotegravir-Long-acting Pre-Exposure Prophylaxis failure and to estimate virologic suppression rates with current first-line standard of care Tenofovir Lamivudine and Dolutegravir therapy
At the conclusion of the Initial Phase data will be assessed to determine the need for and optimal design of a potential Second Phase the details of which will not be described in this protocol Should the investigator find sub-optimal virologic suppression rates on Tenofovir Lamivudine and Dolutegravir regimens in this trial the investigator would then proceed to the Second Phase in which the investigator will compare DarunavirRitonavir based Antiretroviral Therapy with Tenofovir Lamivudine and Dolutegravir in an open-label randomized non-inferiority clinical trial The aim of the second phase will be to determine whether an alternative to the predominant first-line regimen in much of the world will be required to optimise virologic suppression for this population
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