Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

Study Overview
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Brief Summary
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To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).

Official Title
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A Randomised, Double Blind, Placebo-Controlled, Multicentre Study Of UK-427,857 25mg O.D. , 50mg B.I.D., 100mg B.I.D And 300mg B.I.D. In Asymptomatic HIV Infected Patients To Investigate Pharmacodynamics, Pharmacokinetics, Safety And Toleration.

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Maraviroc (UK-427,857)
* Drug: Maraviroc (UK-427,857)
* Drug: Maraviroc (UK-427,857)
* Drug: Maraviroc (UK-427,857)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: Male with HIV or surgically sterilized female with HIV showing no symptoms of HIV Weight between 50 and 90kg and within the permitted range for their height Exclusion Criteria: Exclusion criteria: Subjects with a CD4 count less than 250cells/mm3 or HIV viral load of less than 5000 copies/mL Subjects with acquired immune deficiency syndrome (AIDS) or a previous AIDS diagnosis Subjects whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion Subjects who have taken anti-retroviral drugs in the eight weeks prior to the study screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Maraviroc (UK-427,857)<br>* 25 mg oral tablet once daily for 10 days<br>* Other names: Celsentri, Selzentry;|
| Experimental: B<br> | Drug: Maraviroc (UK-427,857)<br>* 50 mg oral tablet twice daily for 10 days<br>* Other names: Celsentri, Selzentry;|
| Experimental: C<br> | Drug: Maraviroc (UK-427,857)<br>* 100 mg oral tablet twice daily for 10 days<br>* Other names: Celsentri, Selzentry;|
| Experimental: D<br> | Drug: Maraviroc (UK-427,857)<br>* 300 mg oral tablet twice daily for 10 days<br>* Other names: Celsentri, Selzentry;|
| Placebo Comparator: E<br> | Other: Placebo<br>* Matching placebo oral tablet twice daily for 10 days<br>* Other names: Celsentri, Selzentry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in viral load |  | Day 11 | 
| Pharmacokinetic profile of UK-427,857 |  | Days 1 and 10 | 
| Receptor saturation |  | Days 1, 5, 10, 11, 13, 15, 19, 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-lead electrocardiography |  | Days 1-11 and Day 40 | 
| Time course of viral load from baseline to follow-up |  | Days 1-15 and Days 19, 22, 25, 40 | 
| Time to rebound of viral load |  | Days 1-15 and Days 19, 22, 25, 40 | 
| The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations |  | Days 1-11 | 
| The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10) |  | Days 1-11 | 
| The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90) |  | Days 1-11 | 
| Adverse events |  | Days 1-40 | 
| Laboratory safety testing |  | Days 1, 3, 7, 11, 15, 40 | 
| Physical examination |  | Days 1, 11, 40 | 
| Supine and standing blood pressure and pulse rate |  | Days 1-11 and Day 40 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Treatment Naïve