Dolutegravir; Rilpivirine for HIV-1 infection

Inclusion criteria

• {"criterion_text":"- Male or female, aged 18-60 years"}
• {"criterion_text":"- Confirmed HIV-1 seropositive documented"}
• {"criterion_text":"- ART commenced during primary HIV infection, as defined by Fiebig stage"}
• {"criterion_text":"- Plasma HIV-RNA < 50 copies/ml for at least 24 months"}
• {"criterion_text":"- CD4+ T cell count > 350 cells/mm3 at the last routine follow-up visit"}
• {"criterion_text":"- No new AIDS-defining diagnosis or progression of HIV-related disease"}
• {"criterion_text":"- Able to adhere to an effective ART regimen for the duration of the study"}
• {"criterion_text":"- Willing and able to give written informed consent for participation in the study"}

Exclusion criteria

• {"criterion_text":"- Confirmed HIV-2 seropositive"}
• {"criterion_text":"- Women who are pregnant"}
• {"criterion_text":"- History of systemic cancer, such as Kaposi’s sarcoma and lymphoma, or other virusassociated malignancies and/or history of AIDS-defining illness according to Centers for Disease Control and Prevention criteria"}
• {"criterion_text":"- Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both active and chronic hepatitis C virus infection, with detectable virus RNA, and syphilis"}
• {"criterion_text":"- Only Step 2 Naso-pharyngeal swab positive for SARS-CoV-2"}

Primary endpoints

• {"endpoint_text":"- Step 1: To complete the immune-virologic and immune-genetic profiling of volunteers enrolled in the study and perform all the statistical analysis within the time frame proposed (21 months) before the beginning of the MAP cohort recruitment","definition_or_measurement_approach":"Completion of immune-virologic and immune-genetic profiling of enrolled volunteers and performance of all statistical analyses within the proposed 21-month timeframe prior to MAP cohort recruitment."}
• {"endpoint_text":"- Step 2: Proportion of participants who controlled viremia counts (<50%) and maintained a stable CD4 T-cell count = 350 cells/μl for all the follow-up (6 months) (no CD4 significant drop)","definition_or_measurement_approach":"Proportion of participants with viremia counts <50 copies/ml and maintained a stable CD4 T-cell count = 350 cells/μl throughout the 6-month follow-up period."}

Italy

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

15-07-2024

Processing Time Days

32

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy