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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00824421

Purpose

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.

Condition	Intervention	Phase
HIV-1	Drug: UK-453, 061 Drug: EFV +TVA	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2B Multicenter, Randomized, Double-Blind, Comparative Trial Of UK-453,061, In Combination With Tenofovir Df And Emtricitabine Versus Efavirenz In Combination With Tenofovir DF And Emtricitabine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of subjects with HIV-1 RNA <48 copies/mL at 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability as measured by spontaneous adverse event reports, serious adverse events and safety laboratory tests. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analyses. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
UK-453,061 PK parameters AUC24, Cmax, and C24 (PK sub-study). [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
The percentage of subjects with fewer than 48 copies of HIV-1 RNA per milliliter of plasma at 24 and 96 weeks. [ Time Frame: 24-96 weeks ] [ Designated as safety issue: Yes ]
The percentage of subjects with fewer than 400 copies of HIV-1 RNA per milliliter of plasma at 24, 48, and 96 weeks. [ Time Frame: 24-96 weeks ] [ Designated as safety issue: Yes ]
The change from baseline in log10 transformed HIV-1 RNA levels at 24, 48, and 96 weeks. [ Time Frame: 24-96 weeks ] [ Designated as safety issue: Yes ]
The time-averaged difference (TAD) in log10 transformed HIV-1 RNA levels at 24, 48 and 96 weeks. [ Time Frame: 24-96 weeks ] [ Designated as safety issue: Yes ]
The percentage of subjects with virologic response at 48 and 96 weeks. [ Time Frame: 48-96 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in CD4+ count (absolute and percentage) at 24, 48, and 96 weeks. [ Time Frame: 24-96 weeks ] [ Designated as safety issue: Yes ]
Genotypic and phenotypic susceptibility at the time of treatment failure. [ Time Frame: TBD ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	189
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
UK- 453,061 Dose One: Experimental UK 453,061 Dose One plus Truvada	Drug: UK-453, 061 UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
UK-453,061 Dose Two: Experimental UK 453,061 Dose Two plus Truvada	Drug: UK-453, 061 UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
Efavirenz + Truvada: Active Comparator Efavirenz + Truvada	Drug: EFV +TVA Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824421

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Italy
Pfizer Investigational Site
Torino, Italy, 10149

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5271015
Study First Received:	January 15, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00824421
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

HIV-1. Treatment Naive

Study placed in the following topic categories:

Efavirenz
Emtricitabine
HIV Infections

Acquired Immunodeficiency Syndrome
Tenofovir
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 30, 2009