Gilead Sciences has announced significant progress in the enrollment of participants for two Phase II collaborative trials aimed at evaluating lenacapavir, an investigational long-acting option for HIV prevention. These trials, named PURPOSE 3 (HPTN-102) and PURPOSE 4 (HPTN-103), focus on cisgender women and people who inject drugs in the United States.
Enrollment Milestone
The first participants in the PURPOSE 3/HPTN-102 trial were enrolled at a site at the University of California, San Diego, marking a critical milestone in the study. This trial specifically targets cisgender women, with an emphasis on black women and other women of color who are disproportionately affected by HIV.
Focus of the Trials
- PURPOSE 3 (HPTN-102): This trial aims to assess the effectiveness of lenacapavir for HIV prevention in cisgender women. Given the high impact of HIV on black women and women of color, this study is crucial in addressing disparities in HIV prevention and care.
- PURPOSE 4 (HPTN-103): This trial is designed to evaluate lenacapavir’s efficacy among people who inject drugs, another group at high risk for HIV infection.
Collaboration and Funding
These studies are part of a collaborative effort between Gilead and the HIV Prevention Trials Network (HPTN). Gilead sponsors and funds the trials, which are supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).
Importance of Lenacapavir
Lenacapavir is an investigational long-acting HIV prevention drug, and these trials are pivotal in determining its potential to offer a biannual dosing option. Such an option could significantly improve adherence and outcomes in populations at high risk for HIV.
Conclusion
The advancement of these trials represents a crucial step in HIV prevention research. By targeting high-risk groups such as cisgender women of color and people who inject drugs, Gilead aims to develop effective, long-lasting HIV prevention methods that address significant public health needs.
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Source: Clinical Trial Arena