Trials / Terminated
TerminatedNCT00823979
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
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-03-25
- Primary completion
- 2012-10-18
- Completion
- 2012-10-18
- First posted
- 2009-01-16
- Last updated
- 2018-12-04
- Results posted
- 2014-03-14
Locations
63 sites across 13 countries: United States, Brazil, Germany, Italy, Malaysia, Poland, Portugal, Puerto Rico, South Africa, Spain, Taiwan, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00823979. Inclusion in this directory is not an endorsement.