Overview
Sponsor-declared trial summary
HIV-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infection
Step 1: Investigate a set of immune-genetic and viroimmunologic biomarkers that might be useful to individuate PTC Step 2: Validate the Predictive Algorithms of PTC
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 27 Apr 2022 → ongoing
- Decision date (initial)
- 2024-07-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515419-24-00
- EudraCT number
- 2020-006102-23
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacoeconomic, Efficacy
Step 1: Investigate a set of immune-genetic and viroimmunologic biomarkers that
might be useful to individuate PTC
Step 2: Validate the Predictive Algorithms of PTC
Conditions and MedDRA coding
HIV-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 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 < 50 copies/ml for at least 24 months
- CD4+ T cell count > 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
Exclusion criteria 5
- Confirmed HIV-2 seropositive
- Women who are pregnant
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 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)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP30429906 · ATC
- Active substance
- Rilpivirine
- Substance synonyms
- TMC278
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR21 — DOLUTEGRAVIR AND RILPIVIRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Antonella Catsagna
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Antonella Catsagna
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2022-04-27 | 2022-04-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514580-26-00_Redacted | 2.0 |
| Recruitment arrangements (for publication) | Blank document_ not required under directive | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_A_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_A-OS_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_privacy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_genetica_Redacted | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB_JULUCA | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-25 | Italy | Acceptable 2024-07-10
|
2024-07-15 |