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A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00823979
First received: January 15, 2009
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.


Condition Intervention Phase
HIV-1
 Drug: UK-453,061 Dose 1
Drug: UK-453,061 Dose 2
Drug: Etravirine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

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 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of subjects with HIV-1 RNA <50 copies/mL and <400 copies/mL at various time points [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  • The change from baseline in log10 transformed HIV 1 RNA levels [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  • Assessment of Genotypic and phenotypic resistance at various time points [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • The time-averaged difference (TAD) in log10 transformed HIV 1 RNA levels at various time points. [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  • The percentage of subjects with virologic response at different time points. [ Time Frame: 48-96 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell counts (absolute and percentage). [ Time Frame: 24-96 weeks ] [ Designated as safety issue: No ]
  • 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 (to be reported separately). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: March 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UK- 453,061 Dose One Drug: UK-453,061 Dose 1
UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.
Experimental: UK- 453,061 Dose Two Drug: UK-453,061 Dose 2
UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.
Active Comparator: Comparator Drug: Etravirine
Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.

Detailed Description:

The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.

  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 500 copies/mL.
  • Negative urine pregnancy test.

Exclusion Criteria:

  • Suspected or documented active, untreated HIV-1 related opportunistic 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.
  • Previous use of Darunavir or etravirine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823979

  Show 63 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: NCT00823979     History of Changes
Other Study ID Numbers: A5271022
Study First Received: January 15, 2009
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
HIV-1 NNRTI Treatment Experienced
may have Protease inhibitor experience

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

ClinicalTrials.gov processed this record on May 23, 2013