BridgeMD
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 suppression
EU CTIS ID: 2022-503137-66-00
What this study is testing
To evaluate the maintenance of virologic suppression of DTG/3TC at Week 48 post-switch from BIC/FTC/TAF
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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, biopsy results or prior treatment, should be considered by investigators as per protocol to confirm eligibility.
- Participants with unstable liver disease or known biliary abnormalities (except for Gilbert's syndrome, asymptomatic gallstones or otherwise stable chronic liver disease).
- History of liver cirrhosis with or without hepatitis viral co-infection.
- Untreated syphilis infection (positive rapid plasma reagin at Screening). Participants at least 7 days post completed treatment are eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.