MedDataX Logo

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

NCT ID: NCT00823979

Last Updated: 2018-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-25

Study Completion Date

2012-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

NCT00458302

HIV Infections AIDS Virus Human Immunodeficiency Virus +1 more
COMPLETED PHASE3

Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses

NCT00460382

HIV Infections
COMPLETED PHASE2

A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

NCT00002364

HIV Infections
COMPLETED PHASE2

ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past

NCT00004582

HIV Infections
COMPLETED PHASE2

A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients

NCT01199939

Human Immunodeficiency Virus (HIV)
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

UK- 453,061 Dose One

Group Type EXPERIMENTAL

UK-453,061 Dose 1

Intervention Type DRUG

UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.

UK- 453,061 Dose Two

Group Type EXPERIMENTAL

UK-453,061 Dose 2

Intervention Type DRUG

UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.

Comparator

Group Type ACTIVE_COMPARATOR

Etravirine

Intervention Type DRUG

Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UK-453,061 Dose 1

UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.

Intervention Type DRUG

UK-453,061 Dose 2

UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.

Intervention Type DRUG

Etravirine

Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jeffrey Goodman Special Care Clinic

Los Angeles, California, United States

Site Status

Office of Anthony Mills, MD, Inc.

Los Angeles, California, United States

Site Status

CARES

Sacramento, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

Site Status

The Kinder Medical Group

Miami, Florida, United States

Site Status

Care Resource

Miami, Florida, United States

Site Status

Orlando Immunology Center

Orlando, Florida, United States

Site Status

Infectious Diseases Associates of Northwest Florida, PA

Pensacola, Florida, United States

Site Status

Hillsborough County Health Department

Tampa, Florida, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Ruth M. Rothstein CORE Center

Chicago, Illinois, United States

Site Status

Nassau University Medical Center

East Meadow, New York, United States

Site Status

Greiger Clinic

Mount Vernon, New York, United States

Site Status

Rosedale Infectious Diseases

Huntersville, North Carolina, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Saint Hope Foundation - Bellaire Clinic

Bellaire, Texas, United States

Site Status

Saint Hope Foundation - Conroe Clinic

Conroe, Texas, United States

Site Status

Nicholaos C. Bellos, MD, PA

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Saint Hope Foundation - Stafford Clinic

Stafford, Texas, United States

Site Status

Instituto A.Z. de Pesquisa e Ensino

Curitiba, Paraná, Brazil

Site Status

Hospital Geral de Nova Iguacu

Nova Iguaçu, Rio de Janeiro, Brazil

Site Status

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto de Infectologia Campinas

Campinas, São Paulo, Brazil

Site Status

Centro de Referencia e Treinamento DST/AIDS

São Paulo, São Paulo, Brazil

Site Status

Hospital Heliopolis

São Paulo, São Paulo, Brazil

Site Status

Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

Cologne, , Germany

Site Status

Unita' Operativa Malattie Infettive

Bologna, , Italy

Site Status

U.O.S. Immunologia Clinica

Roma, , Italy

Site Status

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Oddzial do Leczenia HIV

Szczecin, , Poland

Site Status

SPZOZ Wojewodzki Szpital Zakazny

Warsaw, , Poland

Site Status

Hospitais da Universidade de Coimbra

Coimbra, , Portugal

Site Status

Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos

Lisbon, , Portugal

Site Status

Centro Hospitalar de Lisboa Ocidental, EPE.

Lisbon, , Portugal

Site Status

Hospital São João

Porto, , Portugal

Site Status

Hospital de Joaquim Urbano

Porto, , Portugal

Site Status

UPR-CTU Pharmacy

San Juan, PR, Puerto Rico

Site Status

Innovative Care PSC

Bayamón, , Puerto Rico

Site Status

Ararat Research Center

Ponce, , Puerto Rico

Site Status

University of Puerto Rico - Medical Sciences Campus - Puerto Rico Medical Center

Rio Piedras, , Puerto Rico

Site Status

HOPE Clinical Research

San Juan, , Puerto Rico

Site Status

Soweto Clinical Trials Centre

Johannesburg, Gauteng, South Africa

Site Status

University of Witwatersrand

Johannesburg, Gauteng, South Africa

Site Status

Chris Hani Baragwanath Hospital

Soweto, Johannesburg, South Africa

Site Status

Dr. J Fourie Medical Centre

Dundee, KwaZulu-Natal, South Africa

Site Status

203 Maxwell Centre

Durban, KwaZulu-Natal, South Africa

Site Status

Willowmead Medical Center

Cape Town, Western Cape, South Africa

Site Status

Desmond Tutu HIV Foundation

Cape Town, Western Cape, South Africa

Site Status

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Department of Infectious Disease, E-Da Hospital

Kaohsiung County, , Taiwan

Site Status

Veterans General Hospital - Taipei

Taipei, , Taiwan

Site Status

Vinnitsa Regional center for AIDS Prevention and Control

Berezyna, Vinnitsa District, Vinnitsa Region, Ukraine

Site Status

Donetsk Regional Center of AIDSs prophylaxis and control

Donetsk, , Ukraine

Site Status

Lugansk Regional Center of AIDS prophylaxis and control

Luhansk, , Ukraine

Site Status

Brighton and Sussex University Hospitals NHS Trust

Brighton, EAST Sussex, United Kingdom

Site Status

North Manchester General Hospital

Crumpsall, Greater Manchester, United Kingdom

Site Status

Royal Infirmary GUM Clinic

Edinburgh, , United Kingdom

Site Status

Western General Hospital

Edinburgh, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-004392-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A5271022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone
NCT01605084 WITHDRAWN PHASE3
Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study
NCT01073761 COMPLETED PHASE1
Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL
NCT02212379 COMPLETED PHASE2
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
NCT00915655 COMPLETED PHASE2
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
NCT00896051 COMPLETED PHASE2
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
NCT01335698 COMPLETED PHASE3
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
NCT04630002 COMPLETED PHASE1
Clinical Trial to Assess the Security of the Dose Reduction of Ritonavir in HIV-Infected Patients in Treatment With Tipranavir/Ritonavir 500/200 mg Every 12 Hours
NCT00607958 COMPLETED PHASE4
NNRTI/PI Toxicity Switch to Darunavir Study
NCT00765154 TERMINATED PHASE4
A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)
NCT00524368 COMPLETED PHASE3
A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
NCT00348673 COMPLETED PHASE2
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
NCT00326716 COMPLETED PHASE1
Study Evaluating the Efficacy of a Reduced Dose Atazanavir in HIV-1-infected Patients
NCT02473328 COMPLETED PHASE2
Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
NCT00543101 COMPLETED PHASE4
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
NCT01274780 COMPLETED PHASE4
A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen
NCT00931463 COMPLETED PHASE4
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
NCT00004581 COMPLETED PHASE3
A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral Combination of Rilpivirine and Ritonavirboosted Darunavir in Therapy-naive HIV-1 Infected Patients.
NCT01736761 COMPLETED PHASE4
Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
NCT00009061 UNKNOWN PHASE3
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
NCT00028301 COMPLETED PHASE3
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
NCT00118898 COMPLETED PHASE3
Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects
NCT01047995 COMPLETED PHASE1
Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients
NCT02238314 COMPLETED PHASE2
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
NCT00838162 COMPLETED PHASE2
Phase IIB Pilot of Atazanavir + Raltegravir
NCT00768989 TERMINATED PHASE2