Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089700
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2004-08-10
Brief Title:
TNX-355 With Optimized Background Therapy OBT in Treatment-Experienced Subjects With HIV-1
Sponsor:
Tanox
Organization:
Tanox
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Three-Arm Study of the Anti-CD4 Monoclonal Antibody TNX-355 With Optimized Background Therapy in Treatment-Experienced Subjects Infected With HIV-1
Status:
UNKNOWN
Status Verified Date:
2005-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 48-week study to compare TNX-355 plus OBT to placebo plus OBT in HIV subjects You must have a stable viral load of at least 10000 copiesml been treated with highly active antiretroviral therapy HAART for at least 6 months be triple class experienced and presently failing or have failed a HAART regimen Subjects will receive infusions every week for 8 weeks then every two weeks
Detailed Description:
This 48-week multicenter randomized double-blinded placebo-controlled multi-dose three-arm safety and efficacy study of approximately 80 subjects will compare TNX-355 plus OBT to placebo plus OBT in adult subjects infected with HIV-1 Subjects must 1 have a stable viral load of 10000 copiesmL determined within 8 weeks prior to randomization Day 1 2 have been treated with HAART for at least 6 months cumulatively 3 be triple class experienced with historical evidence of exposure to each of the three traditional classes of antiretroviral therapy ART nucleoside reverse transcriptase inhibitors NRTIs non-nucleoside reverse transcriptase inhibitors NNRTIs and protease inhibitors PIs and 4 be presently failing or have failed a HAART regimen within 8 weeks prior to screening Screening visit 1
Subjects will be assigned to OBT based upon their past medication history and the results of the virus sensitivity testing PSGT ViroLogic Inc and then randomized to a study arm to begin receiving OBT plus study medication at the Day 1 visit Fusionentry inhibitors will not be permitted as part of the optimized background therapy All subjects will be randomized equally 111 ratio in a double-blinded fashion among three arms to receive OBT plus one of the following Arm A alternating intravenous infusions of TNX-355 15 mgkg and placebo weekly for the first 9 doses through the Week 8 visit and then intravenous infusions of TNX-355 15 mgkg every two weeks Arm B TNX-355 10 mgkg intravenous infusions weekly for the first 9 doses through the Week 8 visit and then intravenous infusions of TNX-355 10 mgkg every two weeks or Arm C weekly intravenous infusions of placebo for the first 9 doses through the Week 8 visit and then intravenous infusions of placebo every two weeks
Subjects will continue to receive blinded therapy until that therapy fails Subjects that do not achieve a viral load reduction of at least 05 log10 from their baseline value on two consecutive protocol-defined assessments after Week 12 will be considered virologic failures Subjects that experience virologic failure after Week 16 ie earliest point at which virologic failure can be confirmed after Week 12 will have the option of being assigned to new OBT plus open-label TNX-355 given as a 15 mgkg infusion every two weeks Subjects that experience a second virologic failure will be discontinued from the study The total duration of study treatment will be 48 weeks with the primary endpoint at Week 24
Subjects will be assigned to OBT based upon their past medication history and the results of the virus sensitivity testing PSGT ViroLogic Inc and then randomized to a study arm to begin receiving OBT plus study medication at the Day 1 visit Fusionentry inhibitors will not be permitted as part of the optimized background therapy All subjects will be randomized equally 111 ratio in a double-blinded fashion among three arms to receive OBT plus one of the following Arm A alternating intravenous infusions of TNX-355 15 mgkg and placebo weekly for the first 9 doses through the Week 8 visit and then intravenous infusions of TNX-355 15 mgkg every two weeks Arm B TNX-355 10 mgkg intravenous infusions weekly for the first 9 doses through the Week 8 visit and then intravenous infusions of TNX-355 10 mgkg every two weeks or Arm C weekly intravenous infusions of placebo for the first 9 doses through the Week 8 visit and then intravenous infusions of placebo every two weeks
Subjects will continue to receive blinded therapy until that therapy fails Subjects that do not achieve a viral load reduction of at least 05 log10 from their baseline value on two consecutive protocol-defined assessments after Week 12 will be considered virologic failures Subjects that experience virologic failure after Week 16 ie earliest point at which virologic failure can be confirmed after Week 12 will have the option of being assigned to new OBT plus open-label TNX-355 given as a 15 mgkg infusion every two weeks Subjects that experience a second virologic failure will be discontinued from the study The total duration of study treatment will be 48 weeks with the primary endpoint at Week 24
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