Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05295394
Status:
WITHDRAWN
Last Update Posted:
2022-04-12
First Post:
2019-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study
Sponsor:
Pedro Cahn
Organization:
Study Overview
Official Title:
Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment, We did not find participants with the M184V mutation , inclusion criteria , throughout 230 resistance tests carried out
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PADDLE184V
Brief Summary:
The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients with a documented M184V mutation.
Detailed Description:
This is a pilot study designed to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV-1 subjects ≥ 18 years old carrying the M184V mutation
This will be evaluated as the proportion of patients with pVL \< 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
This study will consist of a screening period of up to 42 days, a 48-week treatment period, followed by a 4-week post-treatment follow-up (FU) period to document late adverse events.
The study will include 20 HIV-1-infected subjects, meeting all inclusion criteria and not meeting any exclusion criteria for this study.
This will be evaluated as the proportion of patients with pVL \< 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
This study will consist of a screening period of up to 42 days, a 48-week treatment period, followed by a 4-week post-treatment follow-up (FU) period to document late adverse events.
The study will include 20 HIV-1-infected subjects, meeting all inclusion criteria and not meeting any exclusion criteria for this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: