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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Safety and tolerability will be assessed by monitoring adverse experiences.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •HIV-1 is CCR5 tropic virus only.
- •CCR5 antagonist treatment naive.
- •BMI > 16 to < 32 kg/m
- •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.
排除标准
- •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
研究组 & 干预措施
Treatment A - INCB009471 100mg IR
INCB009471, 100 mg IR orally once daily
干预措施: INCB009471 (Drug)
Treatment B - INCB009471 300mg SR
INCB009471, 300 mg SR orally once daily
干预措施: INCB009471 (Drug)
Treatment C - Placebo
Placebo matching INCB009471
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Safety and tolerability will be assessed by monitoring adverse experiences.
时间窗: Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.
次要结局
- 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.(Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.)