WHO ICTRP trial
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender…
EUCTR2023-001025-23-Outside-EU/EEA · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2023-001025-23-Outside-EU/EEA |
|---|---|
| Public title | Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People 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 Non-binary People = 16 Years of Age who Have Sex with Male… |
| Primary sponsor | Gilead Sciences, Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Argentina;Peru;Brazil;Mexico;South Africa;Thailand;United States |
| Conditions | Pre-Exposure Prophylaxis of HIV Infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Virus Diseases [C02] |
| Interventions | Trade Name: Sunlenca Product Name: Lenacapavir Pharmaceutical Form: Solution for injection INN or Proposed INN: Lenacapavir sodium Current Sponsor code: GS-6207 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal… |
| Registration date | Feb 14, 2025 |
| Secondary IDs | GS-US-528-9023 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: