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

PHASE2TerminatedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

March 25, 2009

Primary Completion Date

October 18, 2012

Study Completion Date

October 18, 2012

Conditions
HIV-1
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.

Trial Locations (63)

1818

Soweto Clinical Trials Centre, Johannesburg

2013

Chris Hani Baragwanath Hospital, Soweto

2193

University of Witwatersrand, Johannesburg

3000

Dr. J Fourie Medical Centre, Dundee

4001

203 Maxwell Centre, Durban

7780

Willowmead Medical Center, Cape Town

7925

Desmond Tutu HIV Foundation, Cape Town

10550

Greiger Clinic, Mount Vernon

11554

Nassau University Medical Center, East Meadow

15586

Hospital Raja Perempuan Zainab II, Kota Bharu

23222

Vinnitsa Regional center for AIDS Prevention and Control, Berezyna

28046

Hospital Universitario La Paz, Madrid

28078

Rosedale Infectious Diseases, Huntersville

30308

AIDS Research Consortium of Atlanta, Atlanta

32504

Infectious Diseases Associates of Northwest Florida, PA, Pensacola

32803

Orlando Immunology Center, Orlando

33133

The Kinder Medical Group, Miami

33137

Care Resource, Miami

33602

Hillsborough County Health Department, Tampa

40138

Unita' Operativa Malattie Infettive, Bologna

50937

Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin, Cologne

59100

University Malaya Medical Centre, Kuala Lumpur

60612

Ruth M. Rothstein CORE Center, Chicago

75204

Nicholaos C. Bellos, MD, PA, Dallas

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77301

Saint Hope Foundation - Conroe Clinic, Conroe

77401

Saint Hope Foundation - Bellaire Clinic, Bellaire

77477

Saint Hope Foundation - Stafford Clinic, Stafford

82445

Department of Infectious Disease, E-Da Hospital, Kaohsiung County

83045

Donetsk Regional Center of AIDSs prophylaxis and control, Donetsk

90028

Jeffrey Goodman Special Care Clinic, Los Angeles

90069

Office of Anthony Mills, MD, Inc., Los Angeles

91045

Lugansk Regional Center of AIDS prophylaxis and control, Luhansk

94121

San Francisco Veterans Affairs Medical Center, San Francisco

95814

CARES, Sacramento

95817

University of California Davis Medical Center, Sacramento

45267-0405

University of Cincinnati Medical Center, Cincinnati

80240-280

Instituto A.Z. de Pesquisa e Ensino, Curitiba

26030-381

Hospital Geral de Nova Iguacu, Nova Iguaçu

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

13015-080

Instituto de Infectologia Campinas, Campinas

04121-000

Centro de Referencia e Treinamento DST/AIDS, São Paulo

04231-030

Hospital Heliopolis, São Paulo

00184

U.O.S. Immunologia Clinica, Roma

71-455

Oddzial do Leczenia HIV, Szczecin

01-201

SPZOZ Wojewodzki Szpital Zakazny, Warsaw

3000-075

Hospitais da Universidade de Coimbra, Coimbra

1169-050

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

1349-019

Centro Hospitalar de Lisboa Ocidental, EPE., Lisbon

4200-319

Hospital São João, Porto

4369-004

Hospital de Joaquim Urbano, Porto

00935

UPR-CTU Pharmacy, San Juan

University of Puerto Rico - Medical Sciences Campus - Puerto Rico Medical Center, Rio Piedras

00959

Innovative Care PSC, Bayamón

00717-1563

Ararat Research Center, Ponce

00909

HOPE Clinical Research, San Juan

08916

Hospital Universitari Germans Trias I Pujol, Badalona

Unknown

Veterans General Hospital - Taipei, Taipei

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

M8 5RB

North Manchester General Hospital, Crumpsall

EH3 9HA

Royal Infirmary GUM Clinic, Edinburgh

EH4 2XU

Western General Hospital, Edinburgh

NW3 2QG

Royal Free Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY