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 | Terminated Phase 2 Results DMC

• 2 other identifiers: A52710222007-004392-19
• Study Type: interventional
• Target: 105
• Locations: 13 countries
• Sites: 63

Brief 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

HIV-1

Keywords

HIV-1 NNRTI Treatment Experienced; may have Protease inhibitor experience

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24

  Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

  Week 24

Secondary Outcomes (11)

• Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96

  Weeks 48, 96

• Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96

  Week 24, 48, 96

• Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

  Baseline, Week 24, 48, 96

• Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

  Week 24, 48, 96

• Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96

  Week 24, 48, 96

Study Arms (3)

UK- 453,061 Dose One

EXPERIMENTAL

Drug: UK-453,061 Dose 1

UK- 453,061 Dose Two

EXPERIMENTAL

Drug: UK-453,061 Dose 2

Comparator

ACTIVE COMPARATOR

Drug: Etravirine

Interventions

UK-453,061 Dose 1 DRUG

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

UK- 453,061 Dose One

UK-453,061 Dose 2 DRUG

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

UK- 453,061 Dose Two

Etravirine DRUG

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

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (63)

Jeffrey Goodman Special Care Clinic

Los Angeles, California, 90028, United States

Location

Office of Anthony Mills, MD, Inc.

Los Angeles, California, 90069, United States

Location

CARES

Sacramento, California, 95814, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

The Kinder Medical Group

Miami, Florida, 33133, United States

Location

Care Resource

Miami, Florida, 33137, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Infectious Diseases Associates of Northwest Florida, PA

Pensacola, Florida, 32504, United States

Location

Hillsborough County Health Department

Tampa, Florida, 33602, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Ruth M. Rothstein CORE Center

Chicago, Illinois, 60612, United States

Location

Nassau University Medical Center

East Meadow, New York, 11554, United States

Location

Greiger Clinic

Mount Vernon, New York, 10550, United States

Location

Rosedale Infectious Diseases

Huntersville, North Carolina, 28078, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0405, United States

Location

Saint Hope Foundation - Bellaire Clinic

Bellaire, Texas, 77401, United States

Location

Saint Hope Foundation - Conroe Clinic

Conroe, Texas, 77301, United States

Location

Nicholaos C. Bellos, MD, PA

Dallas, Texas, 75204, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Saint Hope Foundation - Stafford Clinic

Stafford, Texas, 77477, United States

Location

Instituto A.Z. de Pesquisa e Ensino

Curitiba, Paraná, 80240-280, Brazil

Location

Hospital Geral de Nova Iguacu

Nova Iguaçu, Rio de Janeiro, 26030-381, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Instituto de Infectologia Campinas

Campinas, São Paulo, 13015-080, Brazil

Location

Centro de Referencia e Treinamento DST/AIDS

São Paulo, São Paulo, 04121-000, Brazil

Location

Hospital Heliopolis

São Paulo, São Paulo, 04231-030, Brazil

Location

Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

Cologne, 50937, Germany

Location

Unita' Operativa Malattie Infettive

Bologna, 40138, Italy

Location

U.O.S. Immunologia Clinica

Roma, 00184, Italy

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Oddzial do Leczenia HIV

Szczecin, 71-455, Poland

Location

SPZOZ Wojewodzki Szpital Zakazny

Warsaw, 01-201, Poland

Location

Hospitais da Universidade de Coimbra

Coimbra, 3000-075, Portugal

Location

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

Lisbon, 1169-050, Portugal

Location

Centro Hospitalar de Lisboa Ocidental, EPE.

Lisbon, 1349-019, Portugal

Location

Hospital São João

Porto, 4200-319, Portugal

Location

Hospital de Joaquim Urbano

Porto, 4369-004, Portugal

Location

UPR-CTU Pharmacy

San Juan, PR, 00935, Puerto Rico

Location

Innovative Care PSC

Bayamón, 00959, Puerto Rico

Location

Ararat Research Center

Ponce, 00717-1563, Puerto Rico

Location

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

Rio Piedras, 00935, Puerto Rico

Location

HOPE Clinical Research

San Juan, 00909, Puerto Rico

Location

Soweto Clinical Trials Centre

Johannesburg, Gauteng, 1818, South Africa

Location

University of Witwatersrand

Johannesburg, Gauteng, 2193, South Africa

Location

Chris Hani Baragwanath Hospital

Soweto, Johannesburg, 2013, South Africa

Location

Dr. J Fourie Medical Centre

Dundee, KwaZulu-Natal, 3000, South Africa

Location

203 Maxwell Centre

Durban, KwaZulu-Natal, 4001, South Africa

Location

Willowmead Medical Center

Cape Town, Western Cape, 7780, South Africa

Location

Desmond Tutu HIV Foundation

Cape Town, Western Cape, 7925, South Africa

Location

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Department of Infectious Disease, E-Da Hospital

Kaohsiung County, 82445, Taiwan

Location

Veterans General Hospital - Taipei

Taipei, Taiwan

Location

Vinnitsa Regional center for AIDS Prevention and Control

Berezyna, Vinnitsa District, Vinnitsa Region, 23222, Ukraine

Location

Donetsk Regional Center of AIDSs prophylaxis and control

Donetsk, 83045, Ukraine

Location

Lugansk Regional Center of AIDS prophylaxis and control

Luhansk, 91045, Ukraine

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, EAST Sussex, BN2 1ES, United Kingdom

Location

North Manchester General Hospital

Crumpsall, Greater Manchester, M8 5RB, United Kingdom

Location

Royal Infirmary GUM Clinic

Edinburgh, EH3 9HA, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Interventions

etravirine

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: March 25, 2009
• Primary Completion: October 18, 2012
• Study Completion: October 18, 2012
• Last Updated: December 4, 2018
• Results First Posted: March 14, 2014

Record last verified: 2018-11

Locations

BR (6); US (21); IT (2); MY (2); DE (1); ES (2); ZA (7); TW (2); GB (5); PR (5); PL (2); UA (3); PT (5)