A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

Study Overview
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Brief Summary
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A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.

Official Title
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A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

Conditions
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HIV-1

Intervention / Treatment
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* Drug: UK-453,061
* Drug: UK-453,061


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive. Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay. Exclusion Criteria: Patients with a CD4 count less than 250 cells/mm3. Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion. Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).

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

Sexes Eligible for Study
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Male

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: Stage 1<br> | Drug: UK-453,061<br>* Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days<br>|
| Experimental: Stage 2<br> | Drug: UK-453,061<br>* Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8 | Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1. | Baseline, Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load | Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported. | Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose]) |