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Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
EU CTIS ID: 2024-511054-50-00
What this study is testing
Phase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing bictegravir/emtricitabine/tenofovir alafenamide (BVY; coformulated, Biktarvy®) in virologically suppressed PWH at Week 24 Phase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48
- Phase II and Phase III (Integrated)
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
- Participants must meet all of the following inclusion criteria to be eligible for participation in this study: Participants 18 years of age or older and able to understand and give written informed consent.
- Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
- Receiving BVY for ≥ 24 weeks prior to screening.
You likely can't join if
- Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study: Prior use of, or exposure to LEN, GS-1720, or GS-4182.
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance.
- Have been treated within 6 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic [at least 4 weeks] systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies).
- Participation in any other clinical study, including observational studies, without prior approval from the Sponsor is prohibited while participating in this study.
- Positive serum pregnancy test at screening or positive pregnancy test at Day 1.
- Participants with plans to breastfeed during the study period and within 60 days following the last dose of study drug.
See the full eligibility criteria
- Participants must meet all of the following inclusion criteria to be eligible for participation in this study: Participants 18 years of age or older and able to understand and give written informed consent.
- Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
- Receiving BVY for ≥ 24 weeks prior to screening.
- Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study: Prior use of, or exposure to LEN, GS-1720, or GS-4182.
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance.
- Have been treated within 6 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic [at least 4 weeks] systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies).
- Participation in any other clinical study, including observational studies, without prior approval from the Sponsor is prohibited while participating in this study.
- Positive serum pregnancy test at screening or positive pregnancy test at Day 1.
- Participants with plans to breastfeed during the study period and within 60 days following the last dose of study drug.
- Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period or active malignancy requiring acute systemic treatment.
- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
- Requirement for ongoing therapy with or prior use of any prohibited medications.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements, including medical history of psychotic disorder and/or use of antipsychotic medications prescribed for psychosis.
- History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
- Documented INSTI resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
- Prior use of any Long Acting (LA) parenteral antiretrovirals (ARVs) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
- Any of the following laboratory values at screening: a) CD4 cell count < 200 cells/mm3 at screening b) Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula c) Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN) d) Direct bilirubin > 1.5 × ULN e) Platelets count < 50,000 cells/mm3 f) Hemoglobin < 8.0 g/dL
- Active tuberculosis infection.
- Active or occult hepatitis B virus (HBV) infection as defined below (regardless of other HBV serologic results). Participants found to be susceptible to HBV infection should be recommended to receive an HBV vaccination. a) Hepatitis B surface antigen positive (HBsAg+) (or) b) Hepatitis B core antibody positive (HBcAb+) and hepatitis B surface antibody negative (HBsAb-).
- Active hepatitis C virus (HCV) defined as detectable HCV RNA. Note: Participants with prior/inactive HCV infection (defined as undetectable HCV RNA) may enroll.
- Moderate/severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Puerto Rico
- Japan
- Canada
- Switzerland
- Taiwan
- Australia
- Korea, Republic of
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 United States; United Kingdom; Puerto Rico; Japan; Canada; Switzerland and 3 more location(s). 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.