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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 22, 2021
Last Update Posted : January 19, 2024
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Sponsor:
Gilead Sciences
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Gilead Sciences
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 142 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 |
| Actual Primary Completion Date : | December 19, 2023 |
| Estimated Study Completion Date : | November 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ISL+LEN
Participants will receive the following for at least 48 weeks:
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Drug: ISL
Capsules administered orally without regard to food Drug: LEN Tablets administered orally without regard to food
Other Name: GS-6207 |
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Experimental: B/F/TAF
Participants will receive the following for at least 48 weeks:
After 48 weeks, participants will switch from B/F/TAF to ISL+LEN
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 :
- 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 :
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Change From Baseline in Clusters of Differentiation 4 (CD4)+ Cell Count at Week 12 [ Time Frame: Baseline, Week 12 ]
- Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ]
- Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation [ Time Frame: Up to 5 years ]
- 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.
- 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.
- 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.
- 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).
- 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.
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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 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.
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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.
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
Locations
Show 44 study locations
Sponsors and Collaborators
Gilead Sciences
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Additional Information:
| 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: | January 19, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |