Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: HIV Infections
In brief
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
Key facts
- Study ID
- NCT00393120
- Run by
- Incyte Corporation
- People needed
- 45
- Starts
- 2006-10-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2018-03-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Study site — Los Angeles, California, United States
- Study site — Washington D.C., District of Columbia, United States
- Study site — Orlando, Florida, United States
- Study site — Vero Beach, Florida, United States
- Study site — Boston, Massachusetts, United States
- Study site — Annandale, Virginia, United States
Full record on ClinicalTrials.gov
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