Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gilead Sciences Inc.

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

11 Oct 2024 → ongoing

Decision date (initial)

2024-08-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Gilead Sciences Ltd.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Prophylaxis

Compare LEN and F/TDF persistence among people who would benefit from PrEP

Secondary objectives 3

1. Evaluate the safety of LEN and F/TDF
2. Evaluate acceptability of LEN and F/TDF
3. Evaluate the pharmacokinetics (PK) of LEN

Conditions and MedDRA coding

Human Immunodeficiency Virus (HIV-1) infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
2. Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people
3. At least 18 years of age at screening
4. Increased likelihood of HIV acquisition as indicated by at least one of the following: a) Condomless sex with ≥ 2 partners in the past 6 months b) Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months c) Engagement in sex work or transactional sex in the past 12 months d) Use of ≥ 2 courses of nonoccupational HIV postexposure prophylaxis (nPEP) in the past 12 months e) Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months
5. Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening
6. Estimated glomerular filtration rate (eGFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr): (140 - age in years) × (weight in kg) x [0.85 if female] = CLcr (mL/min) 72 × (serum creatinine in mg/dL)
7. Body weight at least 35 kg
8. Willing and able to follow study procedures
9. Participants of childbearing potential who are receiving teratogenic medications, including testosterone, who engage in frontal (vaginal) intercourse must not intend to become pregnant during the study and must agree to utilize protocol-specified method(s) of contraception as described in Appendix 11.4. of the Protocol.

Exclusion criteria 14

1. Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
2. Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
3. Current use of PrEP, defined as self-report of the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation.
4. Current use of nPEP, unless the prescribed course will be completed prior to randomization.
5. Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product).
6. Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection a) If a participant has a negative hepatitis B surface antigen (HBsAg), negative hepatitis B surface antibody (HBsAb), and positive hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) DNA testing will be completed. If the HBV DNA result is positive, the participant is a screen failure. Participants found to be susceptible to HBV infection will be offered HBV vaccination. b) If the hepatitis C virus (HCV) Ab result is positive, then HCV RNA will be evaluated. Participants found to be positive for HCV at screening must not have active infection or must have completed treatment and achieved a sustained virologic response.
7. Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding).
8. Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).
9. Need for continued use of any contraindicated concomitant medications.
10. Have a history of osteoporosis or bone fragility fractures.
11. Current alcohol or substance abuse judged by the investigator to be problematic such that it potentially interferes with participant study adherence.
12. Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable.Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable.
13. Participants of childbearing potential who are pregnant or lactating at screening or on Day 1. Participants of childbearing potential must have a negative pregnancy test at screening and on Day 1 (see “Definition of Childbearing Potential” in Appendix 11.4 of the Protocol).
14. Any other clinical condition, laboratory abnormalities, or psychosocial 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. On-time LEN injection at Day 1/baseline and Week 26 and on-time follow-up visit at Week 52
2. Dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations consistent with ≥ 4 doses/week (≥ 700 fmol/punch) at Weeks 13, 26, 39, and 52

Secondary endpoints 3

1. Treatment-emergent adverse events and treatment emergent laboratory abnormalities
2. Questionnaire outcomes related to general acceptability of LEN and F/TDF
3. LEN plasma concentrations at Weeks 26 and 52

Investigational products

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

Test 2

Comparator 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 CT Support

Public contact point

Organisation

Gilead Sciences Inc.

Contact name

EU CT Support

Third parties 9

Locations

1 EU/EEA country · 6 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 56 files

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

Application history

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