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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05729568




Registration number
NCT05729568
Ethics application status
Date submitted
6/02/2023
Date registered
15/02/2023

Titles & IDs
Public title
A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Scientific title
A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection
Secondary ID [1] 0 0
GS-US-536-5939
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Teropavimab
Treatment: Drugs - Zinlirvimab
Treatment: Drugs - Lenacapavir Tablet
Treatment: Drugs - Lenacapavir Injection
Treatment: Drugs - Antiretroviral Therapy

Experimental: Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B - Participants will receive oral LEN 600mg, subcutaneous (SC) LEN 927 mg, teropavimab Dose A, and zinlirvimab Dose B on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. The last treatment regimen will include SC LEN + teropavimab Dose A + zinlirvimab Dose B.

Experimental: Randomized Phase: Antiretroviral Therapy (ART) - Participants will continue their baseline oral ART through Week 52.

Experimental: Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B - At Week 52, participants who receive the study drug of LEN, teropavimab, zinlirvimab, and complete study through Week 52 with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL will be given the option to participate in the study extension phase, where they will continue to receive their randomized study drugs treatment regimen until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years.

Experimental: Extension Phase: ART - Participants who complete study through Week 52 with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound (VR) throughout the randomized phase of the study will be given the option to participate in the extension phase and receive the study drugs of LEN, teropavimab, and zinlirvimab at the dose specified for randomized phase until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years. Treatment with study drug will begin at Week 52 and at that time the baseline oral ART will be discontinued.


Treatment: Drugs: Teropavimab
Administered intravenously

Treatment: Drugs: Zinlirvimab
Administered intravenously

Treatment: Drugs: Lenacapavir Tablet
Administered orally

Treatment: Drugs: Lenacapavir Injection
Administered subcutaneously

Treatment: Drugs: Antiretroviral Therapy
Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants with Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) = 50 copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 26
Secondary outcome [1] 0 0
Proportion of Participants with HIV-1 RNA = 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 26
Timepoint [4] 0 0
Baseline, Week 26
Secondary outcome [5] 0 0
Change from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 52
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [6] 0 0
First dose date up to end of study (Up to approximately 6 years)
Secondary outcome [7] 0 0
Trough Concentration at Week 26 for GS-5423, GS-2872, and LEN
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Trough Concentration at Week 52 for GS-5423, GS-2872, and LEN
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Pharmacokinetic (PK) Parameter: AUC0-t for GS-5423, GS-2872, and LEN
Timepoint [9] 0 0
First dose date up to end of study (Up to approximately 6 years)
Secondary outcome [10] 0 0
PK Parameter: AUClast for GS-5423, GS-2872, and LEN
Timepoint [10] 0 0
First dose date up to end of study (Up to approximately 6 years)
Secondary outcome [11] 0 0
PK Parameter: t1/2 for GS-5423, GS-2872, and LEN
Timepoint [11] 0 0
First dose date up to end of study (Up to approximately 6 years)
Secondary outcome [12] 0 0
PK Parameter: Cmax for GS-5423, GS-2872, and LEN
Timepoint [12] 0 0
First dose date up to end of study (Up to approximately 6 years)
Secondary outcome [13] 0 0
PK Parameter: Tmax for GS-5423, GS-2872, and LEN
Timepoint [13] 0 0
First dose date up to end of study (Up to approximately 6 years)
Secondary outcome [14] 0 0
Proportion of Participants with Treatment-emergent Anti-GS-5423 Antibodies
Timepoint [14] 0 0
Up to end of study (Up to approximately 6 years)
Secondary outcome [15] 0 0
Proportion of Participants with Treatment-emergent Anti-GS-2872 Antibodies
Timepoint [15] 0 0
Up to end of study (Up to approximately 6 years)

Eligibility
Key inclusion criteria
Key

* On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for = 1 year prior to screening visit 2. A change in ART regimen = 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.
* No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or = 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q).
* Plasma HIV-1 RNA < 50 copies/mL at screening visit 2.
* Documented plasma HIV-1 RNA < 50 copies/mL for = 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL). Virologic elevations of = 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.
* Proviral pheynotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening.
* Screening CD4+ T-cell count = 200 cells/µL at screening visit 2.

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Comorbid condition requiring ongoing immunosuppression.
* Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
* Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2.
* History of opportunistic infection or illness indicative of Stage 3 HIV disease.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 NSW - Sydney
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Canada
State/province [15] 0 0
Toronto
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05729568