Study to evaluate virological efficacy, safety tolerability of the to 2-drug therapy with DTG/3TC FDC or the antiretroviral tenofovir (TAF or TDF) -containing regimen (T-CR) in HIV-1 infected virologically suppressed wome

Phase 1

• Conditions: HIV-1-infected adult women of >18 years of age, without previous virologic failure, currently receiving an effective (HIV-RNA < 50 copies/ml) triple-drug cART, containing tenofovir (TAF or TDF) in the regimen; MedDRA version: 20.0Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002565-17-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 290

Inclusion Criteria

Major inclusion criteria:
· Female individuals
· HIV-1 documented infection
· Age > 18 years
· Being on an effective (pVL < 50 copies/ml) three-drug cART regimen containing tenofovir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TDF/F/PI/c; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) for at least 3 months before the screening. Two consecutive HIV-1 RNA determinations below the determination threshold before enrollment are required
· No known allergy or intolerance to NRTIs, NNRTIs or INSTIs
· Women of childbearing potential will be required to adopt an effective birth control system throughout the study period
· Subjects 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Major exclusion criteria:
· Having failed virologically any previous ART regimen
· Evidence of any 3TC (presence of M184V/I or K65R/E/N) or INSTI resistance
· Having ever been treated with mono or dual ARV therapies subsequently intensified to three-drug cART regimen
· Pregnancy or breast-feeding or not willing to use effective contraception if they are of child-bearing potential
· An active malignancy or OI requiring active treatment (prophylactic regimens are allowed)
· HBV infection
· A life expectancy < 2 years

Study & Design

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