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NCT00393120 · ClinicalTrials.gov registry record · Phase 2

Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients

A Phase 2 study of HIV Infections, sponsored by Incyte Corporation.

Completed
Registry status
Phase 2
Development phase
45
Enrollment target
6
Study locations

NCT00393120 is a Phase 2 study of HIV Infections that has completed, run by Incyte Corporation. The registered enrollment target is 45 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT00393120, a Phase 2 study of HIV Infections, has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 2
Development phase
45 participants
Enrollment target
6
Study locations

Study 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 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

Conditions Studied

HIV Infections

Interventions

  • DRUG Placebo comparator
  • DRUG INCB009471

Study Locations (6)

Florida

  • - Orlando
  • - Vero Beach

California

  • - Los Angeles

District of Columbia

  • - Washington D.C.

Massachusetts

  • - Boston

Virginia

  • - Annandale

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2006-10
Est. Completion 2007-09
Phase Phase 2

Sponsor

Incyte Corporation

239 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00393120

The ClinicalTrials.gov registry entry for NCT00393120 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (90% lower). The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo comparator is the first listed.

NCT00393120 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00393120 about?

NCT00393120 is a clinical study titled "Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients". 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....

What is the current status of trial NCT00393120?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2006-10. Estimated completion is 2007-09.

What conditions does trial NCT00393120 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00393120?

The interventions under investigation include: Placebo comparator (DRUG), INCB009471 (DRUG).

Who is sponsoring clinical trial NCT00393120?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00393120 being conducted?

This trial has 6 study locations across California, District of Columbia, Florida, Massachusetts, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.