Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393120
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : March 26, 2018
Information provided by:
Incyte Corporation

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: INCB009471 Drug: Placebo comparator Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Treatment A - INCB009471 100mg IR
INCB009471, 100 mg IR orally once daily
Drug: INCB009471
100mg SR (sustained release) orally once daily

Experimental: Treatment B - INCB009471 300mg SR
INCB009471, 300 mg SR orally once daily
Drug: INCB009471
300mg SR (sustained release) orally once daily

Placebo Comparator: Treatment C - Placebo
Placebo matching INCB009471
Drug: Placebo comparator
Orally once daily

Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393120

Layout table for location information
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
Layout table for investigator information
Study Director: Richard Levy, MD Incyte Corporation

Layout table for additonal information
Responsible Party: Rich Levy, MD, Incyte Corporation Identifier: NCT00393120     History of Changes
Other Study ID Numbers: INCB 9471-201
INCB 9471-201 ( Other Identifier: Incyte Corporation )
IND No.69,030
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Keywords provided by Incyte Corporation:
viral load
viral tropism
HIV-1 infection
Treatment Naive

Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases