Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients

NCT ID: NCT00393120

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-09-30

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:

1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;

2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;

3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment A - INCB009471 100mg IR

INCB009471, 100 mg IR orally once daily

Group Type: EXPERIMENTAL

INCB009471

Intervention Type: DRUG

100mg SR (sustained release) orally once daily

Treatment B - INCB009471 300mg SR

INCB009471, 300 mg SR orally once daily

Group Type: EXPERIMENTAL

INCB009471

Intervention Type: DRUG

300mg SR (sustained release) orally once daily

Treatment C - Placebo

Placebo matching INCB009471

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

Orally once daily

Interventions

INCB009471

100mg SR (sustained release) orally once daily

Intervention Type: DRUG

INCB009471

300mg SR (sustained release) orally once daily

Intervention Type: DRUG

Placebo comparator

Orally once daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Incyte Corporation

Principal Investigators

Richard Levy, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Los Angeles, California, United States

Washington D.C., District of Columbia, United States

Orlando, Florida, United States

Vero Beach, Florida, United States

Boston, Massachusetts, United States

Annandale, Virginia, United States

Countries

United States

Other Identifiers

INCB 9471-201

Identifier Type: OTHER

Identifier Source: secondary_id

IND No.69,030

Identifier Type: -

Identifier Source: secondary_id

INCB 9471-201

Identifier Type: -

Identifier Source: org_study_id