Ph 3b, BIC/FTC/TAF to DTG/3TC FDC, 96 Week switch, efficacy, safety, and tolerability study in ART-experienced older adults living with HIV with virologic suppressio
- Conditions
- Human immunodeficiency virus (HIV)MedDRA version: 20.1Level: LLTClassification code: 10068341Term: HIV-1 infection Class: 10021881Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2022-503137-66-00
- Lead Sponsor
- Viiv Healthcare UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Age at least 50 years at the time of obtaining informed consent. Eligible participants must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures., Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category., Male or female. Female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test at Screening and a negative urine hCG test at Enrolment) and not lactating., Adults Living with HIV-1 with documented plasma HIV-1 RNA <50 c/mL within 3 months prior to Screening., Must have been on uninterrupted ART for =1 year (except for brief periods [less than 30 days] where all ART was stopped due to tolerability and/or safety concerns), Must be on uninterrupted BIC/FTC/TAF for at least 6 months prior to Screening, Plasma HIV-1 RNA <50 c/mL at Screening, No known prior regimen switches due to documented virologic failure (defined as a confirmed plasma HIV 1 RNA =200 c/mL), Participants with unknown full treatment/clinical history beyond 5 years prior to Screening may be eligible upon discussion and agreement with the medical monitor., Participant is capable of giving written informed consent
Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study, History or presence of allergy or intolerance to the study treatment, its components, drugs of their class, or other allergies that contraindicate participation., Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia., Participants with significant suicidality risk, based on investigator judgment or history of suicidal behavior or ideation., Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening., Treatment with radiation therapy, cytotoxic chemotherapeutic agents, or systemic immune suppressants within 28 days of screening., Participants exposed to experimental drugs or vaccines within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever is longer, prior to the first dose of investigational product)., Anwendung eines Behandlungsschemas, das aus einer einzelnen oder einer dualen ART besteht, die in den Behandlungsleitlinien nicht empfohlen wird., Any known history of regimen switches due to virologic failure (confirmed plasma HIV 1 RNA =200 c/mL), Participants receiving protocol-defined prohibited medications who are unwilling or unable to switch to an alternate medication, Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation in any available prior resistance genotype assay test result., Active CDC Stage 3 disease is excluded, except for cutaneous Kaposi's sarcoma not needing systemic therapy. CD4 cell counts below 200 cells/mm3 (historical or current) are not exclusionary, Participants with verified Grade 4 laboratory abnormalities, except for Grade 4 lipid abnormalities., Alanine aminotransferase (ALT) levels =5 times the upper limit of normal (ULN) or ALT =3xULN with bilirubin =1.5xULN (with >35% direct bilirubin), Participants with estimated creatine clearance <30mL/min per 1.73 m2 using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration method, Participants currently or expected to participate in another interventional study after randomization, unless previously approved by the study medical monitor, Participants showing signs and symptoms suggestive of active SARS-CoV-2 infection within 14 days before enrolment, Participants with severe hepatic impairment (Class C) as per Child-Pugh classification., Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening: •Participants positive for hepatitis B surface antigen (HBsAg) are excluded •Participants negative for hepatitis B surface antibody (anti-HBs) but positive for hepatitis B core antibody (anti-HBc), regardless of their HBsAg status or HBV DNA results, are excluded •Participants who test positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (indicating past and/or current evidence of immunity to HBV) are immune to HBV and are not excluded., Participants with HCV co-infection are eligible if: liver enzymes meet entry criteria; there is no anticipated requirement for concomitant HCV treatment with potential adverse drug interactions, and HCV disease has undergone appropriate work-up and is not advanced or associated with cirrhosis. Additional information e.g., imaging,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method