HIV-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: JULUCA
Product Name: ART
Product Code: [ART]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DOLUTEGRAVIR
Current Sponsor code: ART
Concentration unit: mg milligram(s)
Concent
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female, aged 18-60 years Confirmed HIV-1 seropositive documented ART commenced during primary HIV infection, as defined by Fiebig stage Plasma HIV-RNA 350 cells/mm3 at the last routine follow-up visit No new AIDS-defining diagnosis or progression of HIV-related disease Able to adhere to an effective ART regimen for the duration of the study Willing and able to give written informed consent for participation in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Confirmed HIV-2 seropositive Women who are pregnant History of systemic cancer, such as Kaposi’s sarcoma and lymphoma, or other virus-associated malignancies and/or history of AIDS-defining illness according to Centers for Disease Control and Prevention criteria 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 Only Step 2 Naso-pharyngeal swab positive for SARS-CoV-2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Step1: Investigate a set of immune-genetic and viroimmunologic biomarkers that might be useful to individuate PTC Step2: Validate the Predictive Algorithms of PTC;Secondary Objective: Step1: Validation of the immune-genetics platform for the genotyping of KIRs/TRIM22/SNPs regulating HLA-C expression and HLA A-B-C supratyping in a clinical setting Step2: Evaluate the time of HIV-1 plasma load relapse and/or loss of a stable CD4 T-cell count = 350 cells/mm3 occurring in patients subjected to MAP;Primary end point(s): 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 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);Timepoint(s) of evaluation of this end point: STEP 1 - 21 months STEP 2 - 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Step 2: Proportion of participants who controlled viremia without a significant drop of CD4 T-cell counts (50% drop in CD4 cell counts, <350 cells/mm3 and/or symptomatic acute retroviral syndrome; Step 2: Proportion of participants who maintained a CD4 T cell count =350 cells but experienced viral rebound; Step 2: Time to viral rebound during MAP; Step 1: To complete the immune-genetics platform set-up and validation on reference samples;Timepoint(s) of evaluation of this end point: 10 months; 6 months; 6 months; 10 months; 1 years | — |
Countries
Italy
Contacts
Public ContactOspedale San Raffaele
Ospedale San Raffaele
Outcome results
None listed