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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04925752




Registration number
NCT04925752
Ethics application status
Date submitted
28/05/2021
Date registered
14/06/2021

Titles & IDs
Public title
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
Scientific title
A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People = 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection
Secondary ID [1] 0 0
DOH-27-102021-6681
Secondary ID [2] 0 0
GS-US-528-9023
Universal Trial Number (UTN)
Trial acronym
PURPOSE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-Exposure Prophylaxis of HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral Lenacapavir (LEN)
Treatment: Drugs - F/TDF
Treatment: Drugs - Sub-cutaneous (SC) Lenacapavir (LEN)
Treatment: Drugs - Placebo SC LEN
Treatment: Drugs - PTM F/TDF
Treatment: Drugs - PTM Oral LEN
Treatment: Drugs - F/TAF (for US participants only)

Experimental: Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF - Participants will receive the following for approximately 52 weeks:

* Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks
* Oral PTM Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) once daily
* Oral LEN 600 mg on Days 1 and 2

Participants will receive oral LEN if SC injections are not available

Experimental: Blinded Phase: Placebo LEN + F/TDF - Participants will receive the following for approximately 52 weeks:

* SC LEN placebo every 26 weeks
* Oral F/TDF 200/300 mg once daily
* PTM Oral LEN on Days 1 and 2

Participants will receive oral LEN placebo if SC injections are not available

Experimental: LEN Open-Label Extension (OLE) Phase - Participants will be offered entry into the LEN OLE Phase, following the completion of primary analysis, if LEN demonstrates acceptable safety and efficacy in the Randomized Blinded Phase.

Participants randomized to LEN will continue to receive SC LEN 927 mg, every 26 weeks (± 7 days), and have study visits every 13 weeks (± 7 days).

Participants randomized to F/TDF will switch to SC LEN 927 mg on OLE Day 1, Week 26 and every 26 weeks thereafter. Participants will also receive oral LEN 600 mg on OLE Days 1 and 2.

All participants in the LEN OLE Phase will complete the phase, once LEN becomes available or the sponsor decides to discontinue the study, whichever happens first.

After completing the LEN OLE Phase or study discontinuation, participants will transition to local PrEP, including LEN or other options. If a participant exits early, they will complete an ESDD visit, be referred to local PrEP services if needed, and have a 30-day follow-up visit.

Experimental: PK Tail Phase - Participants who prematurely discontinue study drug during blinded phase and participants that were randomized to LEN who choose not to continue in the LEN OLE Phase will transition to the PK Tail Phase. Participants will receive oral F/TDF (or Emtricitabine/Tenofovir Alafenamide (F/TAF) for US participants only) once daily for 78 weeks to cover the PK tail and complete visits every 13 weeks (+/- 7 days).

Upon unblinding, participants who were randomized to F/TDF in the Randomized Blinded Phase who decline to participate in the LEN OLE Phase will complete the ESDD visit, transition to local HIV prevention services, and return for a 30-day follow-up visit.


Treatment: Drugs: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food

Treatment: Drugs: F/TDF
Tablets administered orally

Treatment: Drugs: Sub-cutaneous (SC) Lenacapavir (LEN)
Administered via SC injections

Treatment: Drugs: Placebo SC LEN
Administered via SC injections

Treatment: Drugs: PTM F/TDF
Tablets administered orally

Treatment: Drugs: PTM Oral LEN
Tablets administered orally

Treatment: Drugs: F/TAF (for US participants only)
F/TAF tablets administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence Phase: Background HIV Incidence per 100-Person-Years (PY)
Timepoint [1] 0 0
At Screening
Primary outcome [2] 0 0
Randomized Phase: Number of Participants with Diagnosis of HIV-1 Infection
Timepoint [2] 0 0
When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
Secondary outcome [1] 0 0
Number of Participants with Diagnosis of HIV Among Participants While Adherent to Study Drug
Timepoint [1] 0 0
When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
Secondary outcome [2] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Timepoint [2] 0 0
When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
Secondary outcome [3] 0 0
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Timepoint [3] 0 0
When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)

Eligibility
Key inclusion criteria
Key

Incidence Phase

* CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
* HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months.
* Sexually active with = 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following:

* Condomless receptive anal sex with = 2 partners in the last 12 weeks.
* History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks.
* Self-reported use of stimulants with sex in the last 12 weeks.

Randomized Phase

* Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).
* Estimated glomerular filtration rate (eGFR) = 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).

Key
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Incidence Phase

* Prior use of HIV PrEP (including F/TDF or F/TAF) or HIV postexposure prophylaxis (PEP) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir).
* Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation.

Randomized Phase

* Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection.
* Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
Accrual to date
Final
3295
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
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Illinois
Country [9] 0 0
United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Brazil
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Belo Horizonte - MG
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Brazil
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Canela-Salvador
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Brazil
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Manauas
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Brazil
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Nova Iguaçu
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Mexico
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Guadalajara C.P.
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Peru
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Barranco
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Peru
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Callao
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Peru
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Iquitos
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Peru
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Lima
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Puerto Rico
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San Juan
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Pretoria
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South Africa
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Soshanguvhe
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South Africa
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Tembisa
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South Africa
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Vincent
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Thailand
State/province [46] 0 0
Bangkok
Country [47] 0 0
Thailand
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Chiang Mai
Country [48] 0 0
Thailand
State/province [48] 0 0
Khon Kaen
Country [49] 0 0
Thailand
State/province [49] 0 0
Nonthaburi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04925752