Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-01 @ 6:37 PM
Study NCT ID:
NCT04560569
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
Sponsor:
Frontier Biotechnologies Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Two-Arm, 24-Week Study of Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.
Detailed Description:
This is a Phase 2, multi-center study to evaluate the efficacy, safety, and tolerability of ABT/3BNC117 combination in conjunction with an existing failing antiretroviral therapy (ART) for 1 week, and then with optimized background regimen (OBR) for 24 weeks, respectively. A total of 20 eligible subjects who demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic and/or phenotypic resistance to multiple classes of HIV drugs (3 classes or more) will be enrolled. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load.
Study Oversight
Has Oversight DMC:
True
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?: