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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

NCT00823979 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2018-12-04

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-25
Primary Completion
2012-10-18
Completion
2012-10-18

Countries

  • United States
  • Brazil
  • Germany
  • Italy
  • Malaysia
  • Poland
  • Portugal
  • Puerto Rico
  • South Africa
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00823979 on ClinicalTrials.gov