Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT00385567
Status:
TERMINATED
Last Update Posted:
2010-08-26
First Post:
2006-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of PEHRG214 in HIV-Infected Patients
Sponsor:
Virionyx Corporation Limited
Organization:
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 (\>=1.0 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 (2:1 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 (\>=1.0 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 (2:1 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 laboratory's lower limit of detection and CD4 count of \<220 cells/mm3, 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 U.S. 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 2.0 mg/kg three times weekly for 12 doses. After a "pilot arm" patient has received at least 12 doses of PEHRG214 at 2.0 mg/kg, dose escalation to 4.0 mg/kg 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 4.0 mg/kg, all subsequent patients will enter the protocol at the 4.0 mg PEHRG214/kg level. The subsequent 54 patients will be randomized, in 2:1 ratio within center, to the Treatment group and Control group, respectively. The treatment group will receive PEHRG214 at a dose of 4.0 mg/kg 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 4.0 mg/kg, dose escalation to 8.0 mg/kg 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 2.0 mg/kg three times weekly for 12 doses. After a "pilot arm" patient has received at least 12 doses of PEHRG214 at 2.0 mg/kg, dose escalation to 4.0 mg/kg 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 4.0 mg/kg, all subsequent patients will enter the protocol at the 4.0 mg PEHRG214/kg level. The subsequent 54 patients will be randomized, in 2:1 ratio within center, to the Treatment group and Control group, respectively. The treatment group will receive PEHRG214 at a dose of 4.0 mg/kg 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 4.0 mg/kg, dose escalation to 8.0 mg/kg 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:
True
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?: