Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05052996

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pacific Oaks Medical Group, Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ISL

Drug

Capsules administered orally without regard to food

LEN

Drug

Tablets administered orally without regard to food

Other names: GS-6207

B/F/TAF

Drug

Tablets administered orally without regard to food

Other names: Biktarvy®

ISL/LEN FDC

Drug

Tablets administered orally without regard to food

Primary outcomes

  1. Percentage 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

    The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with the applicable study drug discontinuation status. Week 24 window was between Day 148 and 189 (inclusive). Percentages were rounded off.

Secondary outcomes

  1. Percentage 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

    The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with the applicable study drug discontinuation status. Week 12 window was between Day 71 and 105 (inclusive). Percentages were rounded off.

  2. Percentage 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

    The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with the applicable study drug discontinuation status. Week 48 window was between Day 316 and 378 (inclusive). Percentages were rounded off.

  3. Percentage 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

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with the applicable study drug discontinuation status. Week 12 window was between Day 71 and 105 (inclusive). Percentages were rounded off.

  4. Percentage 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

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with the applicable study drug discontinuation status. Week 24 window was between Day 148 and 189 (inclusive). Percentages were rounded off.

  5. Percentage 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

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with the applicable study drug discontinuation status. Week 48 window was between Day 316 and 378 (inclusive). Percentages were rounded off.

  6. Change From Baseline in Clusters of Differentiation 4 (CD4)+ Cell Count at Week 12

    Time frame: Baseline and Week 12

  7. Change From Baseline in CD4+ Cell Count at Week 24

    Time frame: Baseline and Week 24

  8. Change From Baseline in CD4+ Cell Count at Week 48

    Time frame: Baseline and Week 48

  9. Percentage of Participants Experiencing Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation

    Time frame: Up to 5 years

    TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. Percentages were rounded off.

  10. Cohort 1: Plasma Concentrations for ISL

    Time frame: Anytime postdose at Week 4

  11. Cohort 2: Pharmacokinetic (PK) Parameter: Cmax of Islatravir (ISL)

    Time frame: Anytime post dose on Day 1 and at either Week 12 or Week 18

    Cmax was defined as the maximum observed concentration of drug.

  12. Cohort 2: PK Parameter: Tmax of ISL

    Time frame: Anytime post dose on Day 1 and at either Week 12 or Week 18

    Tmax was defined as the time (observed time point) of Cmax.

  13. Cohort 2: PK Parameter: Ctau of ISL

    Time frame: Anytime post dose at either Week 12 or Week 18

    Ctau was defined as the observed drug concentration at the end of the dosing interval.

  14. Cohort 2: PK Parameter: AUCtau of ISL

    Time frame: Anytime post dose at either Week 12 or Week 18

    AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  15. Plasma Concentrations for LEN

    Time frame: Anytime postdose at Week 4

  16. Cohort 2: Pharmacokinetic (PK) Parameter: Cmax of LEN

    Time frame: Anytime post dose on Day 1, Day 2 and at either Week 12 or 18

    Cmax was defined as the maximum observed concentration of drug.

  17. Cohort 2: PK Parameter: Tmax of LEN

    Time frame: Anytime post dose on Day 1, Day 2 and at either Week 12 or Week 18

    Tmax is defined as the time (observed time point) of Cmax.

  18. Cohort 2: PK Parameter: Ctau of LEN

    Time frame: Anytime post dose at either Week 12 or Week 18

    Ctau was defined as the observed drug concentration at the end of the dosing interval.

  19. Cohort 2: PK Parameter: AUCtau of LEN

    Time frame: Anytime post dose at either Week 12 or Week 18

    AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Sep 22, 2021
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.