Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

HIV-1 Infection Clinical Trial

Official title:

A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05052996
• Other study ID #: GS-US-563-6041
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 5, 2021
• Est. completion date: November 2027

Study information

• Verified date: January 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: November 2027
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for = 24 weeks at screening.

• Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL) for = 24 weeks before and at screening.

• Plasma HIV-1 RNA < 50 copies/mL at screening.

Key Exclusion Criteria:

• History of prior virologic failure while receiving treatment for HIV-1.

• Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN).

• Active, serious infections requiring parenteral therapy < 30 days before randomization.

• Active or occult hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory.

• Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.

• Any of the following laboratory values at screening:

• Creatinine clearance (CLcr) = 30 mL/min according to the Cockcroft-Gault formula

• CD4+ T-cells < 200 cells/mm^3 (Cohort 1); CD4+ T-cells < 350 cells/mm^3 (cohort 2).

• Absolute lymphocyte count < 900 cells/mm^3 (cohort 2).

• Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration.

• Individuals who plan to continue breastfeeding during the study.

• Documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs) resistance mutations in reverse transcriptase, including M184V/I (Cohort 2).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• ISL
Capsules administered orally without regard to food
• LEN
Tablets administered orally without regard to food
• B/F/TAF
Tablets administered orally without regard to food

Locations

Country	Name	City	State
United States	Atlanta ID Group, PC	Atlanta	Georgia
United States	Emory University Hospital Midtown Infectious Disease Clinic	Atlanta	Georgia
United States	Central Texas Clinical Research, LLC	Austin	Texas
United States	Be Well Medical Center	Berkley	Michigan
United States	Pacific Oaks Medical Group	Beverly Hills	California
United States	AccessHealth MA	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Jacobi Medical Center	Bronx	New York
United States	NC TraCS Institute - CTRC: University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	Northstar Healthcare	Chicago	Illinois
United States	AIDS Arms Inc	Dallas	Texas
United States	North Texas Infectious Diseases Consultants, P.A.	Dallas	Texas
United States	Infectious Disease Specialists of Atlanta	Decatur	Georgia
United States	Public Health Institute at Denver Health	Denver	Colorado
United States	Vivent Health	Denver	Colorado
United States	New York-Presbyterian Queens	Flushing	New York
United States	CAN Community Health Care, Inc.	Fort Lauderdale	Florida
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	ID Care	Hillsborough	New Jersey
United States	John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako	Honolulu	Hawaii
United States	The Crofoot Research Center, INC	Houston	Texas
United States	Indiana CTSI Clinical Research Center	Indianapolis	Indiana
United States	JEM Research Institute	Lake Worth	Florida
United States	Huntridge Family Clinic	Las Vegas	Nevada
United States	Mills Clinical Research	Los Angeles	California
United States	Ruane Clinical Research Group, Inc	Los Angeles	California
United States	Schiff Center for Liver Diseases/University of Miami	Miami	Florida
United States	Floridian Clinical Research	Miami Lakes	Florida
United States	Hennepin Healthcare HCMC	New Brighton	Minnesota
United States	Hoag Medical Group - Newport Beach	Newport Beach	California
United States	Orlando Immunology Center	Orlando	Florida
United States	BIOS Clinical Research	Palm Springs	California
United States	Penn Medicine: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Philadelphia FIGHT Community Health Centers	Philadelphia	Pennsylvania
United States	Southampton Healthcare, Inc.	Saint Louis	Missouri
United States	Optimus Medical Group	San Francisco	California
United States	AXCES Research Group	Santa Fe	New Mexico
United States	Chatham County Health Department	Savannah	Georgia
United States	Peter Shalit, M.D.	Seattle	Washington
United States	MultiCare Rockwood Main Clinic	Spokane	Washington
United States	Community Health Care	Tacoma	Washington
United States	The George Washington University Medical Faculty Associates Inc.	Washington	District of Columbia
United States	Washington Health Institute	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With HIV-1 RNA = 50 Copies/mL at Week 24 as Determined by the US Food and Drug Administration (FDA)-defined Snapshot Algorithm		Week 24
Secondary	Proportion of Participants With HIV-1 RNA = 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm		Week 12
Secondary	Proportion of Participants With HIV-1 RNA = 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm		Week 48
Secondary	Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm		Week 12
Secondary	Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm		Week 24
Secondary	Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm		Week 48
Secondary	Change From Baseline in Clusters of Differentiation 4 (CD4)+ Cell Count at Week 12		Baseline, Week 12
Secondary	Change From Baseline in CD4+ Cell Count at Week 24		Baseline, Week 24
Secondary	Change From Baseline in CD4+ Cell Count at Week 48		Baseline, Week 48
Secondary	Percentage of Participants Experiencing Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation		Up to 5 years
Secondary	Pharmacokinetic (PK) Parameter: Cmax of Islatravir (ISL) and Lenacapavir (LEN)	Cmax is defined as the maximum observed concentration of drug.	Day 1 up to Week 36
Secondary	PK Parameter: Tmax of ISL and LEN	Tmax is defined as the time (observed time point) of Cmax.	Day 1 up to Week 36
Secondary	PK Parameter: Ctau of ISL and LEN	Ctau is defined as the observed drug concentration at the end of the dosing interval.	Day 1 up to Week 36
Secondary	PK Parameter: AUCtau of ISL and LEN	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	Day 1 up to Week 36
Secondary	PK Parameter: t1/2 of ISL and LEN	t1/2 is defined as the estimate of the terminal elimination half-life of the drug.	Day 1 up to Week 36

External Links

•   Gilead Clinical Trials Website