Back to resultsPre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1)
Primary Purpose
Pre-Exposure Prophylaxis of HIV Infection
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral Lenacapavir (LEN)
Subcutaneous (SC) Lenacapavir (LEN)
F/TAF
F/TDF
Placebo SC LEN
PTM Oral LEN
PTM F/TAF
PTM F/TDF
Sponsored by
About this trial
This is an interventional prevention trial for Pre-Exposure Prophylaxis of HIV Infection
Eligibility Criteria
Key Inclusion Criteria:
Incidence Phase
- HIV-1 status unknown at initial screening and no prior human immunodeficiency virus ( HIV)-1 testing within the last 3 months
- Sexually active (has had > 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM)
Randomized Phase
- Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing
- Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening
- Body weight ≥ 35 kg
Key Exclusion Criteria:
- Prior receipt of an HIV vaccine
- Prior use of long-acting systemic pre-exposure prophylaxis (PrEP)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Madibeng Centre for Research
- Emavundleni Research Centre
- Vuka Research Clinic
- Desmond Tutu Health Foundation Clinical Trials Unit
- Botha's Hill Clinical Research Site, HIV Prevention Research Unit
- CAPRISA eThekwini Clinical Research Site
- CAPRISA Vulindlela Clinical Research Site
- MatCH Research Unit, Suite 1112, 11th Floor
- Synergy Biomed Research Institute (SBRI)
- Setshaba Research Centre
- Wits Reproductive Health & HIV Institute (Wits RHI)
- The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre
- Perinatal HIV Research Unit (PHRU) Soweto Kliptown
- Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
- Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
- Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
- Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
- Qhakaza Mbokodo Research Clinic
- Africa Health Research Institute
- The Aurum Institute: Pretoria Clinical Research Centre
- The Aurum Institute: Rustenburg Clinical Research Centre
- Desmond Tutu Health Foundation - Masiphumelele Research Office
- The Aurum Institute: Tembisa Clinical Research Centre
- CAPRISA Umlazi Clinical Research Site
- FPD-DTHF Ndevana Community Research Site
- Makerere-Kalangala Clinical Research site
- AMBSO Masaka Clinical Research site
- Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF
Blinded Phase: LEN + PTM F/TDF
Blinded Phase: Placebo LEN + F/TAF
Blinded Phase: Placebo LEN + F/TDF
LEN Open-Label Extension (OLE) Phase
Pharmacokinetic (PK) Tail Coverage Phase
Arm Description
Participants will receive the following for at least 52 weeks: Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks Oral PTM Emtricitabine/Tenofovir Alafenamide (F/TAF) once daily Oral LEN 600 mg on Days 1 and 2
Participants will receive the following for at least 52 weeks: SC 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 the following for at least 52 weeks: SC placebo LEN every 26 weeks Oral F/TAF 200/25 mg once daily Oral PTM LEN on Days 1 and 2
Participants will receive the following for at least 52 weeks: SC placebo LEN every 26 weeks Oral F/TDF 200/300 mg once daily Oral PTM LEN on Days 1 and 2
After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase. Participants randomized to LEN will continue to receive SC LEN 927 mg every 26 weeks for a total of 2 doses. Participants randomized to F/TAF or F/TDF will receive SC LEN 927 mg on OLE Day 1 and OLE Week 26, and will also receive oral LEN 600 mg on OLE Days 1 and 2.
At the completion of the LEN OLE phase, participants will transition into the PK Tail Coverage phase. Additionally, participants that either prematurely discontinue the study drug during the blinded phase or choose not to continue in the LEN OLE phase (if randomized to LEN in the blinded phase) or who discontinue the study drug in the LEN OLE phase are also eligible to transition to the PK Tail Coverage phase. Participants will receive oral F/TDF once daily for 78 weeks beginning 26 weeks after the last LEN injection.
Outcomes
Primary Outcome Measures
Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY)
Randomized Phase: HIV Incidence Reported Per 100-PY of Follow-up
Secondary Outcome Measures
HIV Incidence Among Participants While Adherent to Study Drug
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04994509
Brief Title
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
Acronym
PURPOSE 1
Official Title
A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Exposure Prophylaxis of HIV Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5639 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF
Arm Type
Experimental
Arm Description
Participants will receive the following for at least 52 weeks:
Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks
Oral PTM Emtricitabine/Tenofovir Alafenamide (F/TAF) once daily
Oral LEN 600 mg on Days 1 and 2
Arm Title
Blinded Phase: LEN + PTM F/TDF
Arm Type
Experimental
Arm Description
Participants will receive the following for at least 52 weeks:
SC 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
Arm Title
Blinded Phase: Placebo LEN + F/TAF
Arm Type
Experimental
Arm Description
Participants will receive the following for at least 52 weeks:
SC placebo LEN every 26 weeks
Oral F/TAF 200/25 mg once daily
Oral PTM LEN on Days 1 and 2
Arm Title
Blinded Phase: Placebo LEN + F/TDF
Arm Type
Experimental
Arm Description
Participants will receive the following for at least 52 weeks:
SC placebo LEN every 26 weeks
Oral F/TDF 200/300 mg once daily
Oral PTM LEN on Days 1 and 2
Arm Title
LEN Open-Label Extension (OLE) Phase
Arm Type
Experimental
Arm Description
After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase.
Participants randomized to LEN will continue to receive SC LEN 927 mg every 26 weeks for a total of 2 doses.
Participants randomized to F/TAF or F/TDF will receive SC LEN 927 mg on OLE Day 1 and OLE Week 26, and will also receive oral LEN 600 mg on OLE Days 1 and 2.
Arm Title
Pharmacokinetic (PK) Tail Coverage Phase
Arm Type
Experimental
Arm Description
At the completion of the LEN OLE phase, participants will transition into the PK Tail Coverage phase.
Additionally, participants that either prematurely discontinue the study drug during the blinded phase or choose not to continue in the LEN OLE phase (if randomized to LEN in the blinded phase) or who discontinue the study drug in the LEN OLE phase are also eligible to transition to the PK Tail Coverage phase.
Participants will receive oral F/TDF once daily for 78 weeks beginning 26 weeks after the last LEN injection.
Intervention Type
Drug
Intervention Name(s)
Oral Lenacapavir (LEN)
Other Intervention Name(s)
GS-6207
Intervention Description
Tablets administered orally without regard to food
Intervention Type
Drug
Intervention Name(s)
Subcutaneous (SC) Lenacapavir (LEN)
Other Intervention Name(s)
GS-6207
Intervention Description
Administered via SC injections
Intervention Type
Drug
Intervention Name(s)
F/TAF
Other Intervention Name(s)
Descovy®
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
F/TDF
Other Intervention Name(s)
Truvada®
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo SC LEN
Intervention Description
Administered via SC injections
Intervention Type
Drug
Intervention Name(s)
PTM Oral LEN
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
PTM F/TAF
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
PTM F/TDF
Intervention Description
Tablets administered orally
Primary Outcome Measure Information:
Title
Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY)
Time Frame
At Screening
Title
Randomized Phase: HIV Incidence Reported Per 100-PY of Follow-up
Time Frame
When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
Secondary Outcome Measure Information:
Title
HIV Incidence Among Participants While Adherent to Study Drug
Time Frame
When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame
When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
Title
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Time Frame
When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cisgender Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Incidence Phase
HIV-1 status unknown at initial screening and no prior human immunodeficiency virus ( HIV)-1 testing within the last 3 months
Sexually active (has had > 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM)
Randomized Phase
Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing
Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening
Body weight ≥ 35 kg
Key Exclusion Criteria:
Prior receipt of an HIV vaccine
Prior use of long-acting systemic pre-exposure prophylaxis (PrEP)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Madibeng Centre for Research
City
Brits
ZIP/Postal Code
2500
Country
South Africa
Facility Name
Emavundleni Research Centre
City
Cape Town
ZIP/Postal Code
7750
Country
South Africa
Facility Name
Vuka Research Clinic
City
Cape Town
ZIP/Postal Code
7784
Country
South Africa
Facility Name
Desmond Tutu Health Foundation Clinical Trials Unit
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Botha's Hill Clinical Research Site, HIV Prevention Research Unit
City
Durban
ZIP/Postal Code
3660
Country
South Africa
Facility Name
CAPRISA eThekwini Clinical Research Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
CAPRISA Vulindlela Clinical Research Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
MatCH Research Unit, Suite 1112, 11th Floor
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Synergy Biomed Research Institute (SBRI)
City
East London
Country
South Africa
Facility Name
Setshaba Research Centre
City
Gauteng
ZIP/Postal Code
152
Country
South Africa
Facility Name
Wits Reproductive Health & HIV Institute (Wits RHI)
City
Johannesburg
ZIP/Postal Code
2038
Country
South Africa
Facility Name
The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre
City
Klerksdorp
ZIP/Postal Code
2571
Country
South Africa
Facility Name
Perinatal HIV Research Unit (PHRU) Soweto Kliptown
City
Kliptown
ZIP/Postal Code
1809
Country
South Africa
Facility Name
Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
City
Kwa Zulu Natal
ZIP/Postal Code
4061
Country
South Africa
Facility Name
Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
City
Kwa Zulu Natal
ZIP/Postal Code
4340
Country
South Africa
Facility Name
Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
City
Kwa Zulu Natal
ZIP/Postal Code
4400
Country
South Africa
Facility Name
Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
City
Kwa Zulu Natal
Country
South Africa
Facility Name
Qhakaza Mbokodo Research Clinic
City
Ladysmith
ZIP/Postal Code
3370
Country
South Africa
Facility Name
Africa Health Research Institute
City
Mtubatuba
ZIP/Postal Code
3935
Country
South Africa
Facility Name
The Aurum Institute: Pretoria Clinical Research Centre
City
Pretoria
ZIP/Postal Code
0087
Country
South Africa
Facility Name
The Aurum Institute: Rustenburg Clinical Research Centre
City
Rustenburg
ZIP/Postal Code
299
Country
South Africa
Facility Name
Desmond Tutu Health Foundation - Masiphumelele Research Office
City
Sunnydale
ZIP/Postal Code
7705
Country
South Africa
Facility Name
The Aurum Institute: Tembisa Clinical Research Centre
City
Tembisa
ZIP/Postal Code
1632
Country
South Africa
Facility Name
CAPRISA Umlazi Clinical Research Site
City
Umlazi
ZIP/Postal Code
4066
Country
South Africa
Facility Name
FPD-DTHF Ndevana Community Research Site
City
Vincent
ZIP/Postal Code
5217
Country
South Africa
Facility Name
Makerere-Kalangala Clinical Research site
City
Kalangala
Country
Uganda
Facility Name
AMBSO Masaka Clinical Research site
City
Kyotera- Masaka Region
Country
Uganda
Facility Name
Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd
City
Mityana Town
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-412-5624
Description
Gilead Clinical Trials Website
Learn more about this trial
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
We'll reach out to this number within 24 hrs