Back to resultsSafety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INCB009471
INCB009471
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-infection, viral load, CCR5, viral tropism, HIV-1 infection, Treatment Naive
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment A - INCB009471 100mg IR
Treatment B - INCB009471 300mg SR
Treatment C - Placebo
Arm Description
INCB009471, 100 mg IR orally once daily
INCB009471, 300 mg SR orally once daily
Placebo matching INCB009471
Outcomes
Primary Outcome Measures
Safety and tolerability will be assessed by monitoring adverse experiences.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00393120
Brief Title
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-infection, viral load, CCR5, viral tropism, HIV-1 infection, Treatment Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A - INCB009471 100mg IR
Arm Type
Experimental
Arm Description
INCB009471, 100 mg IR orally once daily
Arm Title
Treatment B - INCB009471 300mg SR
Arm Type
Experimental
Arm Description
INCB009471, 300 mg SR orally once daily
Arm Title
Treatment C - Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching INCB009471
Intervention Type
Drug
Intervention Name(s)
INCB009471
Intervention Description
100mg SR (sustained release) orally once daily
Intervention Type
Drug
Intervention Name(s)
INCB009471
Intervention Description
300mg SR (sustained release) orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Orally once daily
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Levy, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
City
Annandale
State/Province
Virginia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
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Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
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