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| ID | Type | Description | Link |
|---|---|---|---|
| INCB 9471-201 | Other Identifier | Incyte Corporation | |
| IND No.69,030 |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A - INCB009471 100mg IR | Experimental | INCB009471, 100 mg IR orally once daily |
|
| Treatment B - INCB009471 300mg SR | Experimental | INCB009471, 300 mg SR orally once daily |
|
| Treatment C - Placebo | Placebo Comparator | Placebo matching INCB009471 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB009471 | Drug | 100mg SR (sustained release) orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be assessed by monitoring adverse experiences. | Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Levy, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90069 | United States | |||
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| INCB009471 |
| Drug |
300mg SR (sustained release) orally once daily |
|
| Placebo comparator | Drug | Orally once daily |
|
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Orlando | Florida | 32803 | United States |
| Vero Beach | Florida | 32960 | United States |
| Boston | Massachusetts | 02130 | United States |
| Annandale | Virginia | 20037 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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