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

This study has been completed.
Sponsor:
Information provided by:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00393120
First received: October 24, 2006
Last updated: January 20, 2012
Last verified: January 2012

October 24, 2006
January 20, 2012
October 2006
September 2007   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT00393120 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
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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:

  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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV Infections
  • Drug: INCB009471
    100mg SR (sustained release) orally once daily
  • Drug: INCB009471
    300mg SR (sustained release) orally once daily
  • Drug: Placebo comparator
    Orally once daily
  • Experimental: Treatment A - INCB009471 100mg IR
    INCB009471, 100 mg IR orally once daily
    Intervention: Drug: INCB009471
  • Experimental: Treatment B - INCB009471 300mg SR
    INCB009471, 300 mg SR orally once daily
    Intervention: Drug: INCB009471
  • Placebo Comparator: Treatment C - Placebo
    Placebo matching INCB009471
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00393120
INCB 9471-201, INCB 9471-201, IND No.69,030
No
Rich Levy, MD, Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Richard Levy, MD Incyte Corporation
Incyte Corporation
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP