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

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Pfizer

Status and phase

Terminated
Phase 2

Conditions

HIV-1

Treatments

Drug: UK-453,061 Dose 2
Drug: UK-453,061 Dose 1
Drug: Etravirine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00823979
2007-004392-19 (EudraCT Number)
A5271022

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 3 patient groups

UK- 453,061 Dose One
Experimental group
Treatment:
Drug: UK-453,061 Dose 1
UK- 453,061 Dose Two
Experimental group
Treatment:
Drug: UK-453,061 Dose 2
Comparator
Active Comparator group
Treatment:
Drug: Etravirine

Trial contacts and locations

63

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Data sourced from clinicaltrials.gov

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