A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States
PrEP for Women (HPTN 102/Purpose 3): An HIV Prevention Study for Women to Evaluate a Twice a Year PrEP Injection
Sponsor: Gilead Sciences, Inc.
Enrolling: Female Patients Only
Study Length: 130 Weeks
IRB Number: AAAU5744
U.S. Govt. ID: NCT06101329
Contact: Sarita Singh: / ss6550@cumc.columbia.edu
Additional Study Information: PrEP (Pre-Exposure Prophylaxis) is medication that is taken to prevent HIV if a person is exposed to HIV. Research is ongoing to identify PrEP medications that are both convenient and effective. This study is important because women in many areas of New York City have high rates of HIV coupled with low utilization of PrEP. The purpose of HPTN 102/Purpose 3 is to observe how an investigational long-acting injectable HIV prevention medication, Lenacapavir (LEN for short) moves throughout the body in US cisgender women and how they feel receiving an injection every 26 weeks versus taking F/TDF, also known as Truvada, pills daily. There are 2 phases to this study. In the first phase, which lasts one year, you will be randomly assigned to one of two groups: the group that receives LEN or the group that receives Truvada. You will not get to pick which group you are in or which medication you will receive. If assigned to the LEN group, you willreceive two injections on day 1 and two injections again 26 weeks later, given in the fatty area around your stomach. There is a chance the injection will leave a bump under the skin. If assigned to the Truvada group, you will take the tablets by mouth once a day. In the second phase (for up to 1.5 years), every participant will take Truvada by mouth once a day regardless of which group they were in for the first year. The first phase is 52 weeks long and the second phase is an additional 78 weeks making the total length of time for this study approximately 2.5 years. There are at least 13 scheduled visits. Visit procedures include, but are not limited to, a total of four injections if assigned to the LEN group, questionnaires about sexual behaviors, intimate partner violence, family planning as well as physical exams. You will have blood drawn for HIV testing and give urine specimens to test for sexually transmitted infections and pregnancy. You will be compensated for your time and travel at the end of each required study visit.
Investigator
Ellen Morrison, MD, MPH
Do You Qualify?
Are you at least 18 years old? Yes No
Are you living with HIV? Yes No
Were you assigned female at birth? Yes No
Have you been sexually active with a man in the past 12 months? Yes No
Are you interested in taking PrEP? Yes No
Submit
Cancel
You may be eligible for this study

Place Holder




For more information, please contact:
Sarita Singh
ss6550@cumc.columbia.edu