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A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

NCT ID: NCT00824421

Last Updated: 2014-01-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-10-31

Brief Summary

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This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

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Detailed Description

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Conditions

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HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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UK- 453,061 Dose One

UK 453,061 Dose One plus Truvada

Group Type EXPERIMENTAL

UK-453, 061

Intervention Type DRUG

UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

UK-453,061 Dose Two

UK 453,061 Dose Two plus Truvada

Group Type EXPERIMENTAL

UK-453, 061

Intervention Type DRUG

UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

Efavirenz + Truvada

Efavirenz + Truvada

Group Type ACTIVE_COMPARATOR

EFV +TVA

Intervention Type DRUG

Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.

Interventions

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UK-453, 061

UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

Intervention Type DRUG

UK-453, 061

UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

Intervention Type DRUG

EFV +TVA

Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
* HIV 1 RNA viral load of greater then 1,000 copies/mL
* Negative urine pregnancy test.

Exclusion Criteria

* Suspected or documented active, untreated HIV-1 related opportunist infection or other condition requiring acute therapy at the time of randomization.
* Subjects with acute Hepatitis B and/or C within 30 days of randomization.
* Absolute CD4 count \<200 cells/mm3.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Darlinghurst, New South Wales, Australia

Site Status

Pfizer Investigational Site

Melbourne, Victoria, Australia

Site Status

Pfizer Investigational Site

Toronto, Ontario, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Torino, , Italy

Site Status

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Site Status

Pfizer Investigational Site

Bydgoszcz, , Poland

Site Status

Pfizer Investigational Site

Gdansk, , Poland

Site Status

Pfizer Investigational Site

Lodz, , Poland

Site Status

Pfizer Investigational Site

Warsaw, , Poland

Site Status

Pfizer Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Soweto, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Pfizer Investigational Site

Namakgale, Limpopo, South Africa

Site Status

Pfizer Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Pfizer Investigational Site

Pretoria, , South Africa

Site Status

Pfizer Investigational Site

Ch-8091 Zurich, , Switzerland

Site Status

Pfizer Investigational Site

Lugano, , Switzerland

Site Status

Pfizer Investigational Site

Sankt Gallen, , Switzerland

Site Status

Pfizer Investigational Site

Crumpsall, Greater Manchester, United Kingdom

Site Status

Pfizer Investigational Site

Brighton, , United Kingdom

Site Status

Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Countries

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Argentina Australia Canada Italy Mexico Poland South Africa Switzerland United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271015&StudyName=A%20Study%20Of%20Different%20Doses%20Of%20UK-453%2C%20061%20Plus%20Truvada%20Compared%20To%20Efavirenz%20Plus%20Truvada%20In%20Patients%20Who%20Have%20Not%20Been%20Previously

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5271015

Identifier Type: -

Identifier Source: org_study_id

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