Ignite Creation Date:
2024-05-05 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00766597
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2008-10-03
Brief Title:
Safety and Immune Response to Vicriviroc in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase III Open-Label Study to Evaluate the PK Safety Tolerability and Antiviral Activity of Vicriviroc a Novel CCR5 Antagonist in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2015-12
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:
None
Brief Summary:
Complications with current HIV antiretroviral therapy have left many children and adolescents with limited therapeutic options due to drug resistance The purpose of this study is to test the effectiveness and safety of Vicriviroc VCV an HIV entry inhibitor and CCR5 co-receptor antagonist
Detailed Description:
Highly active antiretroviral therapy HAART that includes a protease inhibitor PI or a non-nucleoside reverse transcriptase inhibitor NNRTI has become the standard treatment of HIV-infected adults and children When effective HAART decreases the viral population increases the bodys immune responses and leads to decreased disease progression and increased survival However several factors including poor adherence drug toxicities and drug resistance complicate HIV management and allow for children and adolescents to develop resistance to multiple drug classes leaving them with very limited therapeutic options Fortunately drugs with new mechanisms of action such as HIV entry inhibitors demonstrate activity even in people with resistance to the currently available reverse transcriptase and protease inhibitors
The purpose of this study is to test the effectiveness and safety of Vicriviroc VCV an HIV entry inhibitor Vicriviroc targets the CCR5 chemokine receptor which HIV uses to bind and enter CD4 cells
This study is a two-stage age-stratified non-comparative study to explore the safety tolerability pharmacokinetic profile and antiviral activity of the investigational CCR5 inhibitor Vicriviroc in HIV-infected treatment experienced children and adolescents
In Step I participants will be screened for the co-receptor CCR5 to assess whether they can enter Step II Only participants with CCR5-tropic virus are eligible for Step II - the main portion of the study to evaluate the study outcome measures Those participants who continue to Step II will be assigned to one of four age-stratifies cohorts which will receive varying forms either liquid or tablet of Vicriviroc
Cohort I 12 years to less than 19 years of age to receive tablet formulation of VCV
Cohort II 6 years to less than 12 years of age to receive tablet formulation of VCV
Cohort III 6 years to less than 12 years of age to receive liquid formulation of VCV
Cohort IV 2 years to less than 6 years of age to receive liquid formulation of VCV
Dose strengths of 20 mg and 30 mg will be used or in liquid formulation at a concentration of 1mgmL
Step II is composed of Stage I and Stage II Stage I is a dose ranging study designed to explore how the body responds to different doses of vicriviroc including safety factors associated with dosage After optimal dosage information and safety measures have been assessed for the different cohorts in Stage I Stage II will open Stage II will evaluate the long term safety tolerability and effectiveness of vicriviroc
The study including Steps I and II will last for approximately 48 weeks Follow-up for all subjects exposed to vicriviroc will last for 5 years after initial exposure Visits will be every 3 months for subjects on study provided vicriviroc and every 6 months for subjects who discontinue vicriviroc
The study was terminated shortly after the initiation when the drug company decided to discontinue development of the study drug As of study termination nine participants had enrolled under Cohort I in Step I but only 4 participants had CCR5 tropism and received the study medication under Step II All 4 participants had limited post-baseline data
The purpose of this study is to test the effectiveness and safety of Vicriviroc VCV an HIV entry inhibitor Vicriviroc targets the CCR5 chemokine receptor which HIV uses to bind and enter CD4 cells
This study is a two-stage age-stratified non-comparative study to explore the safety tolerability pharmacokinetic profile and antiviral activity of the investigational CCR5 inhibitor Vicriviroc in HIV-infected treatment experienced children and adolescents
In Step I participants will be screened for the co-receptor CCR5 to assess whether they can enter Step II Only participants with CCR5-tropic virus are eligible for Step II - the main portion of the study to evaluate the study outcome measures Those participants who continue to Step II will be assigned to one of four age-stratifies cohorts which will receive varying forms either liquid or tablet of Vicriviroc
Cohort I 12 years to less than 19 years of age to receive tablet formulation of VCV
Cohort II 6 years to less than 12 years of age to receive tablet formulation of VCV
Cohort III 6 years to less than 12 years of age to receive liquid formulation of VCV
Cohort IV 2 years to less than 6 years of age to receive liquid formulation of VCV
Dose strengths of 20 mg and 30 mg will be used or in liquid formulation at a concentration of 1mgmL
Step II is composed of Stage I and Stage II Stage I is a dose ranging study designed to explore how the body responds to different doses of vicriviroc including safety factors associated with dosage After optimal dosage information and safety measures have been assessed for the different cohorts in Stage I Stage II will open Stage II will evaluate the long term safety tolerability and effectiveness of vicriviroc
The study including Steps I and II will last for approximately 48 weeks Follow-up for all subjects exposed to vicriviroc will last for 5 years after initial exposure Visits will be every 3 months for subjects on study provided vicriviroc and every 6 months for subjects who discontinue vicriviroc
The study was terminated shortly after the initiation when the drug company decided to discontinue development of the study drug As of study termination nine participants had enrolled under Cohort I in Step I but only 4 participants had CCR5 tropism and received the study medication under Step II All 4 participants had limited post-baseline data
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10634 | REGISTRY | None | None |
| IMPAACT P1071 | Registry Identifier | DAIDS ES | None |