Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089466
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2004-08-05
Brief Title:
Safety and Activity of the Oral HIV Entry Inhibitor AMD11070 in HIV Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase IBIIA Dose-Finding Safety and Activity Study of AMD11070 An Orally Administered CXCR4 Entry Inhibitor in HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2012-10
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:
New treatment options are critical for treatment-experienced HIV infected patients with drug resistance HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs This study will test the safety and anti-HIV activity of eight different doses of the HIV entry inhibitor AMD11070 also known as AMD070 in HIV infected patients
Detailed Description:
AMD11070 is an oral HIV-1 entry inhibitor that targets the CXCR4 receptor on T cells AMD11070 has been shown safe and well-tolerated in Phase I clinical trials in HIV uninfected people The goal of this study is to evaluate the safety and antiretroviral activity of eight dose levels of AMD11070 in HIV infected adults with X4-tropic virus Pharmacokinetics PK of AMD11070 will also be studied
This study will last 90 days All participants will receive medication for 10 days There are eight cohorts in this study with a maximum of six participants per cohort Cohort A will receive 200 mg AMD11070 every 12 hours Cohort B will receive 400 mg AMD11070 every 12 hours Cohort C will receive 600 mg AMD11070 every 12 hours Cohort D will receive 800 mg AMD11070 every 12 hours Cohort E will receive 1000 mg AMD11070 daily Cohort F will receive 1500 mg AMD11070 daily Cohort G will receive 1000 mg AMD11070 every 12 hours and Cohort H will receive 2000 mg AMD11070 daily Cohorts B C D and E will open sequentially provided no more than one of six participants in the preceding cohort experiences dose-limiting toxicity DLT based on safety evaluations through Day 17 Cohort G will open to enrollment when Cohort E is filled Cohort H will open to enrollment when Cohort F is filled Cohort F will open to enrollment provided no more than one of six participants of Cohorts E and G experiences DLT All study participants will be offered to receive open-label AMD11070 through a separate long-term safety study
Participants will either be admitted to the general clinical research center GCRC for the dosing period or have dosing PK testing and other study monitoring done on an outpatient basis depending on the study site Participants admitted to the GCRC for the dosing period will be allowed daytime passes from the GCRC on Days 4 6 7 8 and 9 During the study participants will have continuous heart monitoring serial electrocardiograms EKGs and vital sign checks Fasting blood collection will occur on Days 5 and 10 Trough PK testing will occur at entry and on Days 1 2 3 4 6 8 and 11 Intensive 24-hour PK testing and 24-hour urine collection will occur on Days 10 and 11 After treatment targeted physicals and urine collection will occur on Days 17 30 and 90 and additional blood collection will occur on Days 17 21 30 and 90 Participants will undergo an EKG on Days 17 and 90 Participants will also undergo an opthalmologic evaluation and questionnaire sometime after receiving AMD11070
This study will last 90 days All participants will receive medication for 10 days There are eight cohorts in this study with a maximum of six participants per cohort Cohort A will receive 200 mg AMD11070 every 12 hours Cohort B will receive 400 mg AMD11070 every 12 hours Cohort C will receive 600 mg AMD11070 every 12 hours Cohort D will receive 800 mg AMD11070 every 12 hours Cohort E will receive 1000 mg AMD11070 daily Cohort F will receive 1500 mg AMD11070 daily Cohort G will receive 1000 mg AMD11070 every 12 hours and Cohort H will receive 2000 mg AMD11070 daily Cohorts B C D and E will open sequentially provided no more than one of six participants in the preceding cohort experiences dose-limiting toxicity DLT based on safety evaluations through Day 17 Cohort G will open to enrollment when Cohort E is filled Cohort H will open to enrollment when Cohort F is filled Cohort F will open to enrollment provided no more than one of six participants of Cohorts E and G experiences DLT All study participants will be offered to receive open-label AMD11070 through a separate long-term safety study
Participants will either be admitted to the general clinical research center GCRC for the dosing period or have dosing PK testing and other study monitoring done on an outpatient basis depending on the study site Participants admitted to the GCRC for the dosing period will be allowed daytime passes from the GCRC on Days 4 6 7 8 and 9 During the study participants will have continuous heart monitoring serial electrocardiograms EKGs and vital sign checks Fasting blood collection will occur on Days 5 and 10 Trough PK testing will occur at entry and on Days 1 2 3 4 6 8 and 11 Intensive 24-hour PK testing and 24-hour urine collection will occur on Days 10 and 11 After treatment targeted physicals and urine collection will occur on Days 17 30 and 90 and additional blood collection will occur on Days 17 21 30 and 90 Participants will undergo an EKG on Days 17 and 90 Participants will also undergo an opthalmologic evaluation and questionnaire sometime after receiving AMD11070
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 |
|---|---|---|---|
| ACTG A5210 | Registry Identifier | DAIDS ES | None |
| 10020 | REGISTRY | None | None |