Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385567
Status:
TERMINATED
Last Update Posted:
2010-08-26
First Post:
2006-10-01
Brief Title:
A Trial of PEHRG214 in HIV-Infected Patients
Sponsor:
Virionyx Corporation Limited
Organization:
Virionyx Corporation Limited
Study Overview
Official Title:
A Phase 2 Randomized Controlled Trial of PEHRG214 in HIV-Infected Patients
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting eligible patients in timely fashion
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HRG2 is a Phase 2 randomized controlled open-label multi-dose trial to determine the efficacy safety immunogenicity and pharmacokinetic profile of PEHRG214 in HIV-infected patients treated three times weekly for up to 16 weeks
All patients are receiving optimized standard of care HAART
The primary objective of the study is to determine the effect of PEHRG214 in decreasing the viral load 10 log10 as compared to a Control group The primary hypothesis is that treatment with PEHRG214 will result in clinically meaningful and sustained viral load suppression
The total sample size is 70-74 patients from approximately 8-10 participating study centers The first 16-20 patients are enrolled in the non-randomized pilot arm and 54 subsequent patients are randomized 21 within center to Treatment or Control group The total study duration is 7-12 months
All patients are receiving optimized standard of care HAART
The primary objective of the study is to determine the effect of PEHRG214 in decreasing the viral load 10 log10 as compared to a Control group The primary hypothesis is that treatment with PEHRG214 will result in clinically meaningful and sustained viral load suppression
The total sample size is 70-74 patients from approximately 8-10 participating study centers The first 16-20 patients are enrolled in the non-randomized pilot arm and 54 subsequent patients are randomized 21 within center to Treatment or Control group The total study duration is 7-12 months
Detailed Description:
The study design is a randomized controlled open-label multi-dose trial of PEHRG214 administered intravenously three times weekly with the potential for dose escalation in selected patients Patients with HIV infection viral load at least 10 times greater than the site laboratorys lower limit of detection and CD4 count of 220 cellsmm3 will be entered into the trial All patients must be taking an optimized background regimen OBR of antiretroviral agents as confirmed by the Principal Investigator in accordance with the US Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents May 4 2006
A non-randomized pilot arm of 16-20 patients will first receive 20 mgkg three times weekly for 12 doses After a pilot arm patient has received at least 12 doses of PEHRG214 at 20 mgkg dose escalation to 40 mgkg three times weekly will follow a scheme based on adverse event HAGAR and viral load assessments for each individual patient and in certain cases further review by the DSMB After the pilot arm patients have received 12 doses at 40 mgkg all subsequent patients will enter the protocol at the 40 mg PEHRG214kg level The subsequent 54 patients will be randomized in 21 ratio within center to the Treatment group and Control group respectively The treatment group will receive PEHRG214 at a dose of 40 mgkg three times weekly for up to 48 doses 16 weeks The Control group will not receive the investigational drug but will undergo observation while receiving standard of care HAART
After at least 12 doses of PEHRG214 at 40 mgkg dose escalation to 80 mgkg three times weekly will follow a scheme based on adverse event HAGAR and viral load assessments for each individual patient and in certain cases further review by the DSMB
The Control patients will be evaluated every 4 weeks for 16 weeks according to the Schedule of Assessments in Appendix 1F After 16 weeks these patients will have the option of being enrolled in an extension protocol where they can receive PEHRG214
A non-randomized pilot arm of 16-20 patients will first receive 20 mgkg three times weekly for 12 doses After a pilot arm patient has received at least 12 doses of PEHRG214 at 20 mgkg dose escalation to 40 mgkg three times weekly will follow a scheme based on adverse event HAGAR and viral load assessments for each individual patient and in certain cases further review by the DSMB After the pilot arm patients have received 12 doses at 40 mgkg all subsequent patients will enter the protocol at the 40 mg PEHRG214kg level The subsequent 54 patients will be randomized in 21 ratio within center to the Treatment group and Control group respectively The treatment group will receive PEHRG214 at a dose of 40 mgkg three times weekly for up to 48 doses 16 weeks The Control group will not receive the investigational drug but will undergo observation while receiving standard of care HAART
After at least 12 doses of PEHRG214 at 40 mgkg dose escalation to 80 mgkg three times weekly will follow a scheme based on adverse event HAGAR and viral load assessments for each individual patient and in certain cases further review by the DSMB
The Control patients will be evaluated every 4 weeks for 16 weeks according to the Schedule of Assessments in Appendix 1F After 16 weeks these patients will have the option of being enrolled in an extension protocol where they can receive PEHRG214
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