Switch from Efavirenz / emtricitabine / tenofovir difumarate taken once a day or alternate day to Bictegravir / emtricitabine / tenofovir alafenamide in HIV+ patients with suppressed viral load.

Phase 1

• Conditions: HIV infection; MedDRA version: 20.0Level: LLTClassification code 10020441Term: Human immunodeficiency virus infection, unspecifiedSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-003880-79-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Age > 18 years
- Stable treatment with EFV/TDF/FTC either QD or ATAD for at least 24 weeks before the screening
-Virological suppression (HVRNA < 50 cp/mL) for at least 24 weeks before the screening.
-Historical Genotyping Resistance Test (GRT) without known resistance mutations to any antiretroviral drug class
- No previous virological failures on INI-based regimens
- eGFR>50 ml/min
- Women of childbearing potential must accept the use of one of the following contraceptive methods, from the screening for the duration of the study: Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal); progestagogenic hormonal contraceptives associated with an ovulation inhibitor (oral, injectable, implantable); intrauterine devices
d; intrauterine devices with hormonal release system; bilateral tubal ligation; partner's vasectomy; sexual abstinence (hetero).
-Men must agree to specified highly effective method of contraception during heterosexual intercourse or practice sexual abstinence from first dose throughout the study period
- Written informed consent
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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Women who are pregnant or breastfeeding
-HCV co-infection
-Severe hepatic impairment
-Known hypersensitivity to the study drug, the metabolites or formulation excipients
-Presence of an opportunistic infection or an AIDS-defining illness, unless they are directly attributable to the acute seroconversion illness
-Ongoing malignancy (including untreated carcinoma in-situ) other than basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
-Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior the screening.
-Receipt of immunosuppressive medications or immune-modulators within the past 6 months.
-Use of pshycoactive substances which can interfere with patients adherence to the prescribed regimen
-Subjects who do not guarantee an appropriate adherence to the study procedures, according to the investigator’s opinion
-Enrollement in other clinical trials or pharmacological treatment with sperimental drug within the past 30 days.
-Inability to express informed consent

Study & Design

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