Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1)
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| ClinicalTrials.gov Identifier: NCT04994509 |
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Recruitment Status :
Recruiting
First Posted : August 6, 2021
Last Update Posted : May 31, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pre-Exposure Prophylaxis of HIV Infection | Drug: Oral Lenacapavir (LEN) Drug: Subcutaneous (SC) Lenacapavir (LEN) Drug: F/TAF Drug: F/TDF Drug: Placebo SC LEN Drug: PTM Oral LEN Drug: PTM F/TAF Drug: PTM F/TDF | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 5010 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | August 30, 2021 |
| Estimated Primary Completion Date : | March 2024 |
| Estimated Study Completion Date : | July 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF
Participants will receive the following for at least 52 weeks:
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Drug: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Other Name: GS-6207 Drug: Subcutaneous (SC) Lenacapavir (LEN) Administered via SC injections
Other Name: GS-6207 Drug: PTM F/TAF Tablets administered orally |
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Experimental: Blinded Phase: LEN + PTM F/TDF
Participants will receive the following for at least 52 weeks:
|
Drug: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Other Name: GS-6207 Drug: Subcutaneous (SC) Lenacapavir (LEN) Administered via SC injections
Other Name: GS-6207 Drug: PTM F/TDF Tablets administered orally |
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Experimental: Blinded Phase: Placebo LEN + F/TAF
Participants will receive the following for at least 52 weeks:
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Drug: F/TAF
Tablets administered orally
Other Name: Descovy® Drug: Placebo SC LEN Administered via SC injections Drug: PTM Oral LEN Tablets administered orally |
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Experimental: Blinded Phase: Placebo LEN + F/TDF
Participants will receive the following for at least 52 weeks:
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Drug: F/TDF
Tablets administered orally
Other Name: Truvada® Drug: Placebo SC LEN Administered via SC injections Drug: PTM Oral LEN Tablets administered orally |
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Experimental: LEN Open-Label Extension (OLE) Phase
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. |
Drug: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Other Name: GS-6207 Drug: Subcutaneous (SC) Lenacapavir (LEN) Administered via SC injections
Other Name: GS-6207 |
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Experimental: Pharmacokinetic (PK) Tail Coverage Phase
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. |
Drug: F/TDF
Tablets administered orally
Other Name: Truvada® |
- Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY) [ Time Frame: At Screening ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Cisgender Female |
| Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
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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)
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04994509
| Contact: Gilead Clinical Study Information Center | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| Study Director: | Gilead Study Director | Gilead Sciences |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT04994509 |
| Other Study ID Numbers: |
GS-US-412-5624 DOH-27- 072021-6125 ( Registry Identifier: South African National Clinical Trial Registry ) |
| First Posted: | August 6, 2021 Key Record Dates |
| Last Update Posted: | May 31, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Infections Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Disease Attributes Pathologic Processes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Genital Diseases |
Urogenital Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine tenofovir alafenamide Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents |