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

NCT ID: NCT00348673

Last Updated: 2013-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-02-28

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.

Detailed Description

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Conditions

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HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Stage 1

Group Type EXPERIMENTAL

UK-453,061

Intervention Type DRUG

Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days

Stage 2

Group Type EXPERIMENTAL

UK-453,061

Intervention Type DRUG

Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days

Interventions

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UK-453,061

Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days

Intervention Type DRUG

UK-453,061

Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days

Intervention Type DRUG

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cologne, , Germany

Site Status

Pfizer Investigational Site

Frankfurt am Main, , Germany

Site Status

Pfizer Investigational Site

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271010&StudyName=A%20Study%20in%20Asymptomatic%20HIV%20Infected%20Patients%20to%20Investigate%20Pharmacodynamics%2C%20Pharmacokinetics%2C%20Safety%20and%20Toleration%20of%20UK-453%2C061%20

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Other Identifiers

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A5271010

Identifier Type: -

Identifier Source: org_study_id