Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101342
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-10-20
Brief Title:
Study of Lenacapavir and EmtricitabineTenofovir Disoproxil Fumarate FTDF for Prevention of HIV in People Who Inject Drugs HPTN 103
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 2 Open-Label Multicenter Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs
Status:
RECRUITING
Status Verified Date:
2024-09
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 4
Brief Summary:
The goals of this clinical study are to look at how lenacapavir LEN passes through the body and to assess the safety of LEN and emtricitabinetenofovir disoproxil fumarate FTDF for pre-exposure prophylaxis PrEP in people who inject drugs PWID in the United States US
The primary objectives of this study are to characterize the pharmacokinetics PK of LEN and to evaluate the safety of LEN and FTDF for PrEP in US PWID
The primary objectives of this study are to characterize the pharmacokinetics PK of LEN and to evaluate the safety of LEN and FTDF for PrEP in US PWID
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