Study of the genetic, viral and immune response characteristics of a group of patients infected with the AIDS virus treated early and then subjected to suspension of antiretroviral therapy to define biological markers predicting the control of virus replication after pharmacological treatment

Phase 1

• Conditions: HIV-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infection; MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-006102-23-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Male or female, aged 18-60 years
Confirmed HIV-1 seropositivedocumented
ARTcommenced duringprimary 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
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

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

OnlyStep2
Naso-pharyngeal swab positive for SARS-CoV-2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified