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

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ClinicalTrials.gov Identifier: NCT05052996
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : November 18, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: ISL Drug: LEN Drug: B/F/TAF Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: ISL+LEN

Participants will receive the following for at least 48 weeks:

  • ISL 40 mg and LEN 600 mg on Days 1 and 2 (loading dose)
  • ISL 20 mg and LEN 300 mg on Day 8 and every week thereafter
Drug: ISL
Capsules administered orally without regard to food

Drug: LEN
Tablets administered orally without regard to food
Other Name: GS-6207

Experimental: B/F/TAF

Participants will receive the following for at least 48 weeks:

  • bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily

After 48 weeks, participants will switch from B/F/TAF to ISL+LEN

  • ISL 40 mg and LEN 600 mg (loading dose over 2 days)
  • ISL 20 mg and LEN 300 mg 7 days after the first loading dose and every week thereafter

Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.

Drug: ISL
Capsules administered orally without regard to food

Drug: LEN
Tablets administered orally without regard to food
Other Name: GS-6207

Drug: B/F/TAF
Tablets administered orally without regard to food
Other Name: Biktarvy®




Primary Outcome Measures :
  1. 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 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 12 ]
  2. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 48 ]
  3. Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 12 ]
  4. Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 24 ]
  5. Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 48 ]
  6. Change From Baseline in Clusters of Differentiation 4 (CD4)+ Cell Count at Week 12 [ Time Frame: Baseline, Week 12 ]
  7. Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ]
  8. Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]
  9. Percentage of Participants Experiencing Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation [ Time Frame: Up to 5 years ]
  10. Pharmacokinetic (PK) Parameter: Cmax of Islatravir (ISL) and Lenacapavir (LEN) [ Time Frame: Day 1 up to Week 36 ]
    Cmax is defined as the maximum observed concentration of drug.

  11. PK Parameter: Tmax of ISL and LEN [ Time Frame: Day 1 up to Week 36 ]
    Tmax is defined as the time (observed time point) of Cmax.

  12. PK Parameter: Ctau of ISL and LEN [ Time Frame: Day 1 up to Week 36 ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  13. PK Parameter: AUCtau of ISL and LEN [ Time Frame: Day 1 up to Week 36 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  14. PK Parameter: t1/2 of ISL and LEN [ Time Frame: Day 1 up to Week 36 ]
    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.



Information from the National Library of Medicine

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

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 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.

    • Note: Individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
  • Any of the following laboratory values at screening

    • Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
    • Clusters of differentiation 4 (CD4) T cells < 200 cells/mm^3
  • 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

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): NCT05052996


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
Merck Sharp & Dohme Corp.
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: NCT05052996    
Other Study ID Numbers: GS-US-563-6041
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: November 18, 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