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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Adult AIDS Clinical Trials Group |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00089466 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: AMD11070 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IB/IIA Dose-Finding Safety and Activity Study of AMD11070 (An Orally Administered CXCR4 Entry Inhibitor) in HIV-Infected Subjects |
Enrollment: | 6 |
Study Start Date: | November 2004 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
200 mg AMD11070 every 12 hours
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Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
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B: Experimental
400 mg AMD11070 every 12 hours
|
Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
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C: Experimental
600 mg AMD11070 every 12 hours
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Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
|
D: Experimental
800 mg AMD11070 every 12 hours
|
Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
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E: Experimental
1000 mg AMD11070 daily
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Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
|
F: Experimental
1500 mg AMD11070 daily
|
Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
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G: Experimental
1000 mg AMD11070 every 12 hours
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Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
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H: Experimental
2000 mg AMD11070 daily
|
Drug: AMD11070
AMD11070 taken daily. Dosage dependent on arm.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35924-2050 | |
United States, Colorado | |
University of Colorado Health Sciences Center, Denver | |
Denver, Colorado, United States, 80262-3706 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30308 | |
United States, Indiana | |
Indiana University Hospital | |
Indianapolis, Indiana, United States, 46202-5250 | |
Methodist Hospital of Indiana | |
Indianapolis, Indiana, United States, 46202-5250 | |
Wishard Hospital | |
Indianapolis, Indiana, United States, 46202 | |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642-0001 | |
The Cornell Clinical Trials Unit | |
New York, New York, United States, 10021 | |
NYU/Bellevue | |
New York, New York, United States, 10016-6481 | |
Cornell Clinical Trials Unit | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0405 | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 | |
United States, Tennessee | |
Comprehensive Care Clinic | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
University of Texas, Galveston | |
Galveston, Texas, United States, 77555-0435 | |
Dallas VA Medical Center | |
Dallas, Texas, United States, 75235-9173 |
Study Chair: | Michael S. Saag, MD | University of Alabama at Birmingham |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5210 |
Study First Received: | August 5, 2004 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00089466 |
Health Authority: | United States: Food and Drug Administration |
Entry Inhibitors CXCR4 Entry Inhibitors Treatment Experienced Treatment Naive |
Virus Diseases Signs and Symptoms Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |