Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | October 2006 |
| End Date: | September 2007 |
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
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
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
We found this trial at
6
sites
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