Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02483078
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2015-06-24
Brief Title:
Randomized Double-Blind Placebo-Controlled Trial Followed by Single-Arm Treatment of PRO 140
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo-controlled Trial Followed by Single-arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects
Status:
COMPLETED
Status Verified Date:
2022-11
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:
PRO140
Brief Summary:
This is a Phase 2b3 multi-center two part study designed to evaluate the efficacy safety and tolerability of PRO 140 in conjunction with existing ART failing regimen for one week and Optimized Background Therapy OBT for 24 weeks respectively Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes or within two or more drug classes with limited treatment optionsThe options may be limited as a result of drug antiviral class cross-resistance or documented treatment intolerance
Detailed Description:
PRO 140 in combination with other antiretroviral agents is indicated for treatment experienced adult HIV-1 patients infected with CCR5-tropic virus These patients must demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy and have documented genotypic or phenotypic resistance to at least one ART drug within three drug classes or within two or more drug classes with limited treatment option The options may be limited as a result of drug antiviral class cross-resistance documented treatment intolerance documented objective assessments such as renal or hepatic insufficiency eg high creatinine at baseline limiting treatment options due to potential for toxicity past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs
Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes or within two drug classes with limited treatment option
Enrollment will be stratified to have HIV-1 virus resistant to ART drugs within three drug classes or within two drug classes with limited treatment option
The primary objective is to assess the efficacy clinical safety and tolerability parameters of PRO 140 compared to placebo in reducing HIV-1 viral load during the 1-week double-blind treatment period The secondary objectives of the trial are to assess the efficacy clinical safety and tolerability parameters of PRO 140 in combination with Optimized Background Therapy during the 24-week single-arm open-label treatment period
Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes or within two drug classes with limited treatment option
Enrollment will be stratified to have HIV-1 virus resistant to ART drugs within three drug classes or within two drug classes with limited treatment option
The primary objective is to assess the efficacy clinical safety and tolerability parameters of PRO 140 compared to placebo in reducing HIV-1 viral load during the 1-week double-blind treatment period The secondary objectives of the trial are to assess the efficacy clinical safety and tolerability parameters of PRO 140 in combination with Optimized Background Therapy during the 24-week single-arm open-label treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None