Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101329
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-10-20
Brief Title:
Study of Lenacapavir and EmtricitabineTenofovir Disoproxil Fumarate FTDF in Prevention of HIV in Cisgender Women in the United States HPTN 102
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PURPOSE 3
Brief Summary:
The goal of this clinical study is to look at how lenacapavir LEN passes through the body and to assess the safety of LEN and emtricitabinetenofovir disoproxil fumarate FTDF for prevention of HIV in the cisgender women in the US
The primary objectives of this study are 1 to characterize the pharmacokinetics PK of LEN in United States US cisgender women 2 to evaluate the safety of LEN and FTDF for pre-exposure prophylaxis PrEP in US cisgender women and 3 to evaluate the general acceptability of LEN injections and oral FTDF in US cisgender women
The primary objectives of this study are 1 to characterize the pharmacokinetics PK of LEN in United States US cisgender women 2 to evaluate the safety of LEN and FTDF for pre-exposure prophylaxis PrEP in US cisgender women and 3 to evaluate the general acceptability of LEN injections and oral FTDF in US cisgender women
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None