Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PURPOSE 2)
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| ClinicalTrials.gov Identifier: NCT04925752 |
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Recruitment Status :
Recruiting
First Posted : June 14, 2021
Last Update Posted : February 21, 2023
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The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) in preventing the risk of human immunodeficiency virus (HIV) - 1 infection relative to the background HIV-1 incidence rate.
The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a double-blind, randomized study (Randomized Phase). The Incidence Phase will include initial assessments that will provide an estimate of the concurrent background HIV-1 incidence rate. The Randomized Phase of the study will have a Blinded Phase, a LEN Open-label Extension (OLE) Phase, and a pharmacokinetic (PK) Tail Phase.
The primary objective for the Incidence Phase of this study is to estimate the HIV-1 background incidence rate. The primary objective of the Randomized Blinded Phase of this study is to evaluate the efficacy of lenacapavir for HIV-1 pre-exposure prophylaxis (PrEP) in cisgender men (CGM), transgender women (TGW), transgender men (TGM), and gender nonbinary people (GNB) ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pre-Exposure Prophylaxis of HIV Infection | Drug: Oral Lenacapavir (LEN) Drug: F/TDF Drug: Sub-cutaneous (SC) Lenacapavir (LEN) Drug: Placebo SC LEN Drug: PTM F/TDF Drug: PTM Oral LEN Drug: F/TAF (for US participants only) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | June 28, 2021 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | April 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF
Participants will receive the following for at least 52 weeks:
Participants will receive oral LEN if SC injections are not available |
Drug: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Other Name: GS-6207 Drug: Sub-cutaneous (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/TDF
Participants will receive the following for at least 52 weeks:
Participants will receive oral LEN placebo if SC injections are not available |
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/TDF will receive SC LEN 927 mg on OLE Day 1, 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: Sub-cutaneous (SC) Lenacapavir (LEN) Administered via SC injections
Other Name: GS-6207 |
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Experimental: PK Tail Phase
At the completion of the LEN OLE phase, participants will transition into the PK Tail phase. Additionally, participants that prematurely discontinue the study drug during blinded phase and participants that were randomized to LEN who choose not to continue in the LEN OLE Phase are also eligible to 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 beginning 26 weeks after the last injection of LEN. |
Drug: F/TDF
Tablets administered orally
Other Name: Truvada® Drug: F/TAF (for US participants only) F/TAF tablets administered orally once daily |
- Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY) [ Time Frame: At Screening ]
- Randomized Phase: Background HIV Incidence Reported Per 100-PY of Follow-up [ Time Frame: 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) ]
- HIV Incidence Among Participants While Adherent to Study Drug [ Time Frame: 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) ]
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: 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) ]
- Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: 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) ]
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 and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Cisgender male, Transgender male, Transgender female, and Gender non-binary |
| Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
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
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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 Exclusion Criteria:
Incidence Phase
- Prior use of oral PrEP (including F/TDF or F/TAF) 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.
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): NCT04925752
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT04925752 |
| Other Study ID Numbers: |
GS-US-528-9023 DOH-27-102021-6681 ( Other Identifier: South African National Clinical Trial Registry ) |
| First Posted: | June 14, 2021 Key Record Dates |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 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 HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination 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 |