Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-Tropic HIV Infected Patients - Full Text View

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00393120

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: INCB009471	Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
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.

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Proportion of subjects with at least 1.5 log10, 1.0 log10 or 0.5 log10 decline at the end of dosing relative to baseline will be summarized by treatment group with 90% confidence intervals.

Estimated Enrollment:	45
Study Start Date:	October 2006
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393120

Locations

United States, California

Los Angeles, California, United States, 90069
United States, District of Columbia

Washington, District of Columbia, United States, 20007
United States, Florida

Orlando, Florida, United States, 32803

Vero Beach, Florida, United States, 32960
United States, Massachusetts

Boston, Massachusetts, United States, 02130
United States, Virginia

Annandale, Virginia, United States, 20037

Sponsors and Collaborators

Incyte Corporation

More Information

Study ID Numbers:	INCB 9471-201 Amendment #2, INCB009471, IND No.69,030
Study First Received:	October 24, 2006
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00393120
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

HIV-infection
viral load
CCR5

viral tropism
HIV-1 infection
Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009