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

NCT00823979

Last updated date
Study Location
Jeffrey Goodman Special Care Clinic
Los Angeles, California, 90028, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Phase 2b Multicenter, Randomized, Comparative Trial Of Uk-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleotide/Nucleoside Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced Hiv-1 Infected Subjects With Evidence Of Nnrti Resistant Hiv-1
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE HIV-1
Intervention  ICMJE
  • Drug: UK-453,061 Dose 1
    UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.
  • Drug: UK-453,061 Dose 2
    UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.
  • Drug: Etravirine
    Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.
Study Arms  ICMJE
  • Experimental: UK- 453,061 Dose One
    Intervention: Drug: UK-453,061 Dose 1
  • Experimental: UK- 453,061 Dose Two
    Intervention: Drug: UK-453,061 Dose 2
  • Active Comparator: Comparator
    Intervention: Drug: Etravirine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 5, 2013)
105
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2009)
189
Actual Study Completion Date  ICMJE October 18, 2012
Actual Primary Completion Date October 18, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Germany,   Italy,   Malaysia,   Poland,   Portugal,   Puerto Rico,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Argentina,   Canada,   France
 
Administrative Information
NCT Number  ICMJE NCT00823979
Other Study ID Numbers  ICMJE A5271022
2007-004392-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP