- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393120
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
A Randomized, Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability, PK & Virological Effect of Once Daily Oral Dosing of INCB009471 as Monotherapy for 14 Days in ARV-naïve/Limited ARV-experienced, HIV-1 Infected Pts.
This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead electrocardiograms, physical examinations and virologic assessments, including viral load, viral tropism and CD4+ cell count determinations will be performed at the Screening visit and at regularly scheduled visits throughout the study. A blood sample will also be obtained and stored to potentially determine the genotype of the CCR5 receptor.
The primary objectives are:
- Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;
- Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;
- Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90069
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District of Columbia
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Washington, District of Columbia, United States, 20007
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Florida
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Orlando, Florida, United States, 32803
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Vero Beach, Florida, United States, 32960
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Massachusetts
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Boston, Massachusetts, United States, 02130
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Virginia
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Annandale, Virginia, United States, 20037
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Asymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening.
- Males between 18 years and 65 years of age, utilizing adequate contraceptive methods.
- Post menopausal or surgically sterile females between 18 years and 65 years of age. Women of childbearing potential, utilizing adequate contraceptive methods.
- CD4-lymphocyte count >350 cells/mm3
- HIV-1 RNA copies/ml > 10,000.
- HIV-1 is CCR5 tropic virus only.
- CCR5 antagonist treatment naive.
- BMI > 16 to < 32 kg/m2.
- Have no clinically significant findings on screening evaluations, which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.
- Able to comprehend and willing to sign an Informed Consent Form.
Exclusion Criteria:
- Current or recent (<30 days) opportunistic infection.
- Presence of CXCR4- or dual-tropic HIV-1 virus at Screening or Baseline assessments.
- Subjects with chronic renal insufficiency
- Personal history of cardiac diseases.
- History or presence of an abnormal ECG.
- History of unstable ischemic heart disease or uncontrolled hypertension.
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
- Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents and have not recovered from side effects.
- Current treatment or treatment within 30 days or 5 half-lives with another investigational medication or current enrollment in another investigational drug protocol.
- Subjects with unstable medical condition (s), which , in the opinion of the Investigator would compromise their participation in the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A - INCB009471 100mg IR
INCB009471, 100 mg IR orally once daily
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100mg SR (sustained release) orally once daily
300mg SR (sustained release) orally once daily
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Experimental: Treatment B - INCB009471 300mg SR
INCB009471, 300 mg SR orally once daily
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100mg SR (sustained release) orally once daily
300mg SR (sustained release) orally once daily
|
Placebo Comparator: Treatment C - Placebo
Placebo matching INCB009471
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Orally once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability will be assessed by monitoring adverse experiences.
Time Frame: Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.
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Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The virological response to INCB009471 as monotherapy will be assessed by measuring HIV-1 RNA levels by the Roche Amplicor HIV-1 Monitor® Test, v1.5 - Quantitative.
Time Frame: Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.
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Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Richard Levy, MD, Incyte Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCB 9471-201 (Other Identifier: Incyte Corporation)
- IND No.69,030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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