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Study to Evaluate the Safety and Efficacy of GS-5423 and GS-2872 in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

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ClinicalTrials.gov Identifier: NCT04811040
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) GS-5423 and GS-2872 in combination with the HIV capsid inhibitor lenacapavir (LEN).

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Oral Lenacapavir Drug: Subcutaneous Lenacapavir Drug: GS-5423 Drug: GS-2872 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Clinical pharmacologist and sponsor are not masked to treatment assignment.
Primary Purpose: Treatment
Official Title: A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
Actual Study Start Date : April 8, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Lenacapavir (LEN), GS-5423, GS-2872 Dose C
Participants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose C followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose C.
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Name: GS-6207

Drug: Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Other Name: GS-6207

Drug: GS-5423
Administered intravenously
Other Name: 3BNC117-LS

Drug: GS-2872
Administered intravenously
Other Name: 10-1074-LS

Experimental: LEN, GS-5423, GS-2872 Dose D
Participants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose D followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose D.
Drug: Oral Lenacapavir
Tablets administered without regard to food
Other Name: GS-6207

Drug: Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Other Name: GS-6207

Drug: GS-5423
Administered intravenously
Other Name: 3BNC117-LS

Drug: GS-2872
Administered intravenously
Other Name: 10-1074-LS




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: First dose date up to Week 26 ]

Secondary Outcome Measures :
  1. Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 26 ]
  2. Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 52 ]
  3. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 26 ]
  4. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 52 ]
  5. Proportion of Participants With Positive Anti-GS-5423 Antibodies [ Time Frame: Week 26 ]
  6. Proportion of Participants With Positive Anti-GS-5423 Antibodies [ Time Frame: Week 52 ]
  7. Proportion of Participants With Positive Anti-GS-2872 Antibodies [ Time Frame: Week 26 ]
  8. Proportion of Participants With Positive Anti-GS-2872 Antibodies [ Time Frame: Week 52 ]
  9. Change from Baseline in CD4+ Cell Count at Week 26 [ Time Frame: Baseline; Week 26 ]
  10. Change from Baseline in CD4+ Cell Count at Week 52 [ Time Frame: Baseline; Week 52 ]
  11. Proportion of Participants Who Develop Treatment-Emergent Resistance to Lenacapvir (LEN), GS-5423, and GS-2872 [ Time Frame: Day 1 up to Week 52 ]
  12. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to Week 26 ]
  13. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to Week 52 ]
  14. Percentage of Participants Experiencing Treatment-Emergent Severe Adverse Events (SAEs) [ Time Frame: First dose date up to Week 52 ]
  15. Pharmacokinetic (PK) Parameter: AUC0-t of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    AUC0-t is defined as the concentration of drug over time from time zero to time "t".

  16. PK Parameter: AUClast of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  17. PK Parameter: T1/2 of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  18. PK Parameter: Cmax of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Cmax is defined as the maximum observed concentration of drug.

  19. PK Parameter: Tmax of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Tmax is defined as the time (observed time point) of Cmax.

  20. PK Parameter: Tlast of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).

  21. PK Parameter: Ct of GS-5423, and GS-2872, and LEN [ Time Frame: Day 1 up to Week 52 ]
    Ct is the concentration at a particular time (t).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • On first-line antiretroviral therapy (ART) for ≥ 2 years prior to screening. A change in ART regimen ≥ 28 days prior to screening for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed
  • No documented historical resistance to the current ART regimen
  • Plasma HIV-1 RNA < 50 copies/mL at screening
  • Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 18 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
  • Proviral phenotypic sensitivity to both GS-5423 and GS-2872 at screening
  • CD4+ count nadir ≥ 350 cells/μL
  • Screening CD4+ count ≥ 500 cells/μL
  • Availability of a fully active alternative ART regimen, in the opinion of the investigator, in the event of discontinuation of the current ART regimen with development of resistance

Key Exclusion Criteria:

  • Comorbid condition requiring ongoing immunosuppression
  • Evidence of current hepatitis B virus (HBV) infection
  • Evidence of current hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
  • History of opportunistic infection or illness indicative of Stage 3 HIV disease

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811040


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Additional Information:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04811040    
Other Study ID Numbers: GS-US-536-5816
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Infections
Communicable Diseases
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases