Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)

Official Title
-----------------
An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)

Conditions
-----------------
HIV

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic HIV-1 infected male and female patients Weight between 50 and 100kg and within the permitted range for their height Patients with virus that targets CCR5 receptor Exclusion Criteria: Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Maraviroc (UK-427,857)<br>* 150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)<br>* Other names: Celsentri, Selzentry;|
| Experimental: 2<br> | Drug: Maraviroc (UK-427,857)<br>* 100 mg oral tablet once daily while fasted on Days 1-10<br>* Other names: Celsentri, Selzentry;|
| Experimental: 3<br> | Drug: Maraviroc (UK-427,857)<br>* 300 mg oral tablet once daily while fasted on Days 1-10<br>* Other names: Celsentri, Selzentry;|
| Experimental: 4<br> | Drug: Maraviroc (UK-427,857)<br>* 150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)<br>* Other names: Celsentri, Selzentry;|
| Placebo Comparator: 5<br> | Other: Placebo<br>* Matching placebo oral tablet on Days 1-10 (fed and fasted)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in viral load |  | Day 11 | 
| UK-427,857 pharmacokinetics |  | Days 1-11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination |  | Days 1, 11, 40 | 
| 12-lead ECG |  | Days 1-11 and Day 40 | 
| Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10) |  | Days 1-11 | 
| Time course of viral load from baseline to follow-up |  | Days 1-13 and Days 15, 19, 22, 25, 40 | 
| CCR5 receptor saturation |  | Days 1, 5, 10, 11, 13, 15, 19, 40 | 
| Adverse events |  | Days 1-40 | 
| Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90) |  | Days 1-11 | 
| Laboratory safety |  | Days 1, 3, 7, 11, 15, 40 | 
| Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10) |  | Days 1-11 | 
| Supine/standing blood pressure and pulse rate |  | Days 1-11 and Day 40 | 
| Time to rebound of viral load |  | Days 1-13 and Days 15, 19, 22, 25, 40 | 

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