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

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

2 Oct 2024 → ongoing

Decision date (initial)

2024-07-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Gilead Sciences, Inc.

External identifiers

EU CT number

2023-510022-33-00

ClinicalTrials.gov

NCT06333808

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of switching to bictegravir/lenacapavir (BIC/LEN) (75/50 mg) fixed-dose combination (FDC) tablets versus continuing on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets in virologically suppressed people with HIV-1

Secondary objectives 4

1. To evaluate the efficacy of study drug(s) for the 2 treatment groups in virologically suppressed people with HIV-1 as determined by viral load suppression rate and CD4 cell count
2. To evaluate the long-term efficacy of BIC/LEN in participants from Treatment Group 1 as determined by viral load suppression rate and CD4 cell count
3. To evaluate the safety and tolerability of the study drug(s) for the 2 treatment groups
4. To evaluate the long-term safety and tolerability of BIC/LEN in participants from Treatment Group 1

Conditions and MedDRA coding

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 9

1. Aged ≥ 18 years at screening.
2. Currently receiving B/F/TAF for at least 6 months prior to screening.
3. If plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
4. At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
5. Plasma HIV-1 RNA levels < 50 copies/mL at screening.
6. No documented or suspected resistance to BIC (mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
7. No documented or suspected resistance to tenofovir alafenamide (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
8. Estimated glomerular filtration rate > 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr).
9. Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Exclusion criteria 16

1. Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
2. Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
3. Active malignancy requiring acute systemic therapy.
4. Any of the following laboratory values at screening: a) Alanine aminotransferase > 5 × upper limit of normal (ULN) b) Direct bilirubin > 1.5 × ULN c) Platelets < 50,000/mm3 d) Hemoglobin < 8.0 g/dL
5. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3 of the protocol.
6. Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
7. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
8. Breastfeeding (nursing).
9. Prior use of, or exposure to, LEN.
10. Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
11. Active tuberculosis infection.
12. Acute hepatitis < 30 days before randomization.
13. Chronic hepatitis B virus (HBV) infection, as determined by either: a) Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. b) Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
14. Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
15. History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
16. Participants under guardianship, curatorship, or legal protection may not participate in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 7

1. Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm
2. Change from baseline in CD4 cell count at Week 48
3. Proportion of participants from Treatment Group 1 with HIV-1 RNA ≥ 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and open-label [OL] phases) as determined by US FDA–defined snapshot algorithm
4. Proportion of participants from Treatment Group 1 with HIV-1 RNA < 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and OL phases) as determined by US FDA–defined snapshot algorithm
5. Change from baseline in CD4 cell count at Week 96 for participants from Treatment Group 1 (96 weeks on BIC/LEN including blinded and OL phases)
6. Proportion of participants experiencing treatment-emergent adverse events (AEs) through Week 48
7. Proportion of participants from Treatment Group 1 experiencing treatment-emergent AEs through Week 96 (96 weeks on BIC/LEN including blinded and OL phases)

Investigational products

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

Test 2

Comparator 1

Placebo 3

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 CT Support

Public contact point

Organisation

Gilead Sciences Inc.

Contact name

EU CT Support

Third parties 9

Locations

4 EU/EEA countries · 28 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 32 files

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

Application history

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