Early DOlutegravir/LAmivudine Switching after virological suppression (EDOLAS Study)

Phase 1

Active, not recruiting

Conditions: HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL
MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2019-004241-32-IT

Lead Sponsor: SOCIETA' ITALIANA MALATTIE INFETTIVE E TROPICALI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 440

Inclusion Criteria

• HIV-1 documented infection
• Age >=18 years
• To be treated as ART naïve for overall less than 18 months before screening
• To receive a stable (not changed) INSTI-based first-line three-drug ART (see Target Population section for regimens allowed); switch between different NRTIs are allowed
• To have reached a HIV-1 RNA <50 copies/mL during INSTI first-line therapy for less than 12 months. At least a single HIV-1 RNA determination below the threshold within the 6 months before enrollment is required (if a following determination in present, this should not be >=50 copies (cp)/mL)
• No known allergy or intolerance to NRTIs, or INSTIs
• Being able to comply with the protocol requirements
• Informed consent signed
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

Having failed virologically
• Having changed the INSTI drug
• Any major INSTI- or NRTI-resistance-associated mutation documented before starting ART
Pregnancy or breast-feeding
• HBsAg positivity
• HCV-RNA positivity needing for any hepatitis C virus (HCV) therapy during the study
• An active malignancy or opportunistic infection requiring active treatment or primary prophylaxis
• Women of childbearing potential not adopting an effective birth control system throughout the study period
• Creatinine clearance of <50 mL/min/1.73m2 via CKD-EPI method
• A life expectancy <2 years
• Use of HIV immunotherapeutic vaccines; other experimental agents, ART drugs not otherwise specified in the protocol, cytotoxic chemotherapy, systemically administered immunomodulators
• Individuals who in the investigator’s judgment, poses a significant suicidality risk;
• Major Depression, Bipolar Disorders and Psychoses