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Completed

NCT Number: NCT00393120

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

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

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INCB009471

Drug

100mg SR (sustained release) orally once daily

placebo comparator

Drug

Orally once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 26, 2006
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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