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 - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00823979

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

Drug Information available for: Ritonavir Darunavir Etravirine Darunavir ethanolate

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 ]

Estimated Enrollment:	90
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (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.

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

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:	May 10, 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, 2012