Status:
COMPLETED
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Lead Sponsor:
Incyte Corporation
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 HAAR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00393120
Start Date
October 1 2006
End Date
September 1 2007
Last Update
March 26 2018
Active Locations (6)
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1
Los Angeles, California, United States, 90069
2
Washington D.C., District of Columbia, United States, 20007
3
Orlando, Florida, United States, 32803
4
Vero Beach, Florida, United States, 32960