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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00824421
First received: January 15, 2009
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of subjects with HIV-1 RNA <50 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 50 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 ]

Enrollment: 195
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UK- 453,061 Dose One
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.
Experimental: UK-453,061 Dose Two
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.
Active Comparator: Efavirenz + Truvada
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

  Show 31 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00824421     History of Changes
Other Study ID Numbers: A5271015
Study First Received: January 15, 2009
Last Updated: November 23, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Pfizer:
HIV-1. Treatment Naive
HIV Infections
treatment naive

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2013