Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gilead Sciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

17 May 2023 → ongoing

Decision date (initial)

2023-04-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Gilead Sciences, Inc. United States

External identifiers

EU CT number

2022-500929-33-01

ClinicalTrials.gov

NCT05502341

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Pharmacodynamic, Efficacy, Safety

Phase 2: To evaluate the efficacy of switching to a bictegravir (BIC) + lenacapavir (LEN) regimen versus continuing on stable baseline regimen (SBR) in virologically suppressed people with HIV-1 as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24
Phase 3: To evaluate the efficacy of switching to BIC/LEN fixed-dose combination (FDC) tablet regimen versus continuing on a SBR in virologically suppressed people with HIV-1 as determined by the proportion of participants with HIV--1 RNA ≥ 50 copies/mL at Week 48.

Secondary objectives 7

1. Phase 2: To evaluate the efficacy of the 3 treatment regimens in virologically suppressed people with HIV-1 as determined by viral load suppression rate and CD4 cell count at Week 24
2. To evaluate the safety and tolerability of the 3 treatment groups through Week 24
3. To evaluate the pharmacokinetics (PK) of BIC and LEN for participants receiving BIC 75 mg + LEN 25 mg and BIC 75 mg + LEN 50 mg
4. Phase 3: To evaluate the efficacy of the 2 treatment groups in virologically suppressed people with HIV-1 as determined by viral load suppression rate and CD4 cell count at Week 48
5. To evaluate the efficacy of BIC/LEN in participants from Treatment Group 1 as determined by viral load suppression rate and CD4 cell count at Week 96
6. To evaluate the safety and tolerability of the 2 treatment groups through Week 48
7. To evaluate the safety and tolerability of BIC/LEN in participants from Treatment Group 1 through Week 96

Conditions and MedDRA coding

Human Immunodeficiency Virus (HIV-1) infection

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Documented plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels must be < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months prior to the screening visit (Phase 2 only).
2. If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL (Phase 3 only).
3. Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to the components of existing single-tablet regimens, and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows: A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or A regimen containing parenteral agent(s) (excluding a complete long acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
4. No documented or suspected resistance to bictegravir (BIC).
5. Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft- Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

Exclusion criteria 3

1. Prior use of, or exposure to, lenacapavir (LEN)
2. Active tuberculosis infection
3. Chronic hepatitis B virus (HBV) infection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase 2: Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm.
2. Phase 3: Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm.

Secondary endpoints 10

1. Phase 2: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 24 as determined by the US FDA-defined snapshot algorithm.
2. Change from baseline in CD4 cell count at Week 24
3. Proportion of participants experiencing treatment-emergent adverse events (AEs) through Week 24
4. PK parameters Cmax, AUCtau, and Ctau (as applicable) of BIC and LEN
5. Phase 3: Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA–defined snapshot algorithm.
6. Change from baseline in CD4 cell count at Weeks 48.
7. Proportion of participants experiencing treatment-emergent AEs through Week 48.
8. Proportion of participants from Treatment Group 1 with HIV-1 RNA ≥ 50 copies/mL at Week 96 as determined by the US FDA-defined snapshot algorithm
9. Change from baseline in CD4 cell count at Week 96 for participants from Treatment Group 1
10. Proportion of participants from Treatment Group 1 experiencing treatment-emergent AEs through Week 96

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gilead Sciences Inc.

Sponsor organisation

Gilead Sciences Inc.

Address

333 Lakeside Drive

City

Foster City

Postcode

94404-1147

Country

United States

Scientific contact point

Organisation

Gilead Sciences Inc.

Contact name

EU Clinical Trials Support

Public contact point

Organisation

Gilead Sciences Inc.

Contact name

EU Clinical Trials Support

Third parties 8

Locations

4 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 73 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications