LENACAPAVIR, ISLATRAVIR for HIV-1 infection

Inclusion criteria

• {"criterion_text":"- Participants 18 years of age or older at screening and able to understand and give written informed consent.\n- HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by: • One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to screening. • Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL. • During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable (“blip”), as long as it is not confirmed on 2 consecutive visits.\n- Plasma HIV-1 RNA levels < 50 copies/mL at screening.\n- Participants are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.\n- Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception as described in Appendix 11.5.\n- Note: Other protocol defined Inclusion criteria may apply."}

Exclusion criteria

• {"criterion_text":"- Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study: 1) Prior virologic failure. 2) Prior use of, or exposure to, ISL or LEN. 3) Active, serious infections requiring parenteral therapy within 30 days before randomization. 4) Active tuberculosis infection. 5) Acute hepatitis within 30 days before randomization. 6) HBV infection, as determined below at the screening visit: a) Positive HBV surface antigen. OR b) Positive HBV core antibody and negative HBV surface antibody. Note: participants found to be susceptible to HBV infection (eg, negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.\n- Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: participants with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.\n- History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).\n- Treatment < 3 months prior to screening or anticipated treatment during the study period with immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic chemotherapeutic agents without approval from sponsor prior to randomization. Agents disallowed in Section 5.3 may not be considered for sponsor approval.\n- Active malignancy requiring acute systemic therapy.\n- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.\n- Any of the following laboratory values at screening: a) CLcr ≤ 30 mL/min according to the Cockcroft-Gault formula. {Cockcroft 1976} b) Alanine aminotransferase > 5 × upper limit of normal (ULN). c) Direct bilirubin > 1.5 × ULN. d) Platelets < 50,000/μL. e) Hemoglobin < 8.0 g/dL.\n- Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.\n- Known hypersensitivity to any of the study drugs, their metabolites, or formulation excipients.\n- 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 dosing requirements.\n- Participants of childbearing potential (as defined in Appendix 11.5) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration.\n- Participants who plan to continue breastfeeding during the study.\n- Requirement for ongoing therapy or use of any prohibited medications listed in Section 5.3 within 30 days prior to screening through the last dose of study drug.\n- Note: Other protocol defined Exclusion criteria may apply."}

Primary endpoints

• {"endpoint_text":"- The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm [Time Frame: Week 48]","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm; Time Frame: Week 48"}

Secondary endpoints

• {"endpoint_text":"- Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm; Time Frame: Week 96"}
• {"endpoint_text":"- Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 as Determined by the US FDA-Defined Snapshot Algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm; Time Frames: Weeks 48 and 96"}
• {"endpoint_text":"- The change from baseline in CD4+ T-cell count at Weeks 48 and 96","definition_or_measurement_approach":"Absolute change from baseline in CD4+ T-cell count measured at Weeks 48 and 96"}
• {"endpoint_text":"- Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (AEs)","definition_or_measurement_approach":"Proportion of participants who discontinue ISL/LEN due to treatment-emergent AEs (time frame not explicitly restated)"}

Methods

• Recruitment arrangements documents (K1) and flyers (K2) are listed for multiple countries (France, Germany, Spain) in CTIS documents (e.g., K1_GS-US-563-5925_Recruitment_Arrangements_FR_French__Public, K2_GS-US-563-5925_Study-Flyer_DE_German_public, K1_GS-US-563-5925_Recruitment-Arrangements_ES_Public).
• Country-specific recruitment-arrangements PDF listed for France (associatedEntityId 256200).
• Country-specific recruitment-arrangements PDF and Addendum to Recruitment/Informed Consent Procedure listed for Germany (associatedEntityId 256201).
• Country-specific recruitment-arrangements PDF and flyer listed for Spain (associatedEntityId 256199).

France

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

14-01-2026

Processing Time Days

462

Number Of Sites

4

Number Of Participants

25

Germany

Earliest CTIS Part Ii Submission Date

29-11-2024

Latest Decision Or Authorization Date

16-01-2026

Processing Time Days

413

Number Of Sites

5

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

424

Number Of Sites

4

Number Of Participants

32

Primary sponsor

Full Name

Gilead Sciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

Clinical Monitoring, Medical Monitoring, Pharmacovigilance, Site Intelligence and Activation

Third parties

• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Clinical Monitoring, Medical Monitoring, Pharmacovigilance, Site Intelligence and Activation","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Investigator Meetings","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA Services, Medication Adherence","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}