A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Etravirine Administered in Combination With Other Antiretroviral Agents in Antiretroviral Treatment-Experienced HIV-1 Infected Patients
An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Etravirine (ETR) in Combination With Other Antiretrovirals (ARVs) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects
3 other identifiers
interventional
211
11 countries
42
Brief Summary
The purpose of this study is to learn more about the safety and tolerability of etravirine. Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains resistant to other non-nucleotide agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Typical duration for phase_4
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2011
CompletedFirst Posted
Study publicly available on registry
August 23, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedOctober 13, 2014
October 1, 2014
2.2 years
May 19, 2011
October 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants with an Adverse Event (AEs)
48 weeks
Secondary Outcomes (3)
Proportion of Participants with Virologic Suppression [Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) less than (<) 50 copies/Milliliter (mL)] at Week 48
48 weeks
Changes in CD4 Cell Count at Week 48
48 weeks
Changes in Viral Genotype/Phenotype Over Time
48 weeks
Study Arms (1)
Etravirine
EXPERIMENTALInterventions
Type=exact number, unit=mg, number=100, form=tablet, route=oral use, 2 tablets. Type=exact number, unit=mg, number=200, form=tablet, route=oral use, 1 tablet. The drug is taken twice a day, after meals.
Eligibility Criteria
You may qualify if:
- Documented HIV-1 infection
- Treatment with current stable HAART for at least 8 weeks prior to screening
- Currently experiencing virologic failure (screening viral load value \>=500 HIV-1 RNA copies /mL), or switching due to simplification of their regimen or due to adverse event or tolerability reasons, (screening viral load value \<50 HIV-1 RNA copies /mL)
- Demonstrated sensitivity to etravirine and to at least 1 antiretroviral (ARV) agent in the background regimen, based on the resistance test at screening or resistance history or have previously received treatment with etravirine
- Patients agree not to have unprotected sex while on the study
- No currently active AIDS-defining illness
- Did not take any non-ARV investigational agents within 90 days prior to screening
- No use of disallowed treatments
- Adequate liver function
You may not qualify if:
- Any currently active illness or toxicity due to HIV infection
- Any active clinically significant disease or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
North Hollywood, California, United States
Unknown Facility
Fort Laudersale, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Longview, Texas, United States
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
Rosario, Argentina
Unknown Facility
Le Kremlin-Bicêtre, France
Unknown Facility
Paris, France
Unknown Facility
Guatemala City, Guatemala
Unknown Facility
Guadalajara, Mexico
Unknown Facility
México, Mexico
Unknown Facility
Iquitos, Peru
Unknown Facility
Lima, Peru
Unknown Facility
San Juan, Puerto Rico
Unknown Facility
Brasov, Romania
Unknown Facility
Constanța, Romania
Unknown Facility
Craiova, Romania
Unknown Facility
Timișoara, Romania
Unknown Facility
Krasnodar, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Smolensk, Russia
Unknown Facility
Volgograd, Russia
Unknown Facility
Voronezh, Russia
Unknown Facility
Bloemfontein, South Africa
Unknown Facility
Boksburg, South Africa
Unknown Facility
Dundee, South Africa
Unknown Facility
Durban, South Africa
Unknown Facility
Johannesburg, South Africa
Unknown Facility
Newtown, South Africa
Unknown Facility
Port Elizabeth, South Africa
Unknown Facility
Pretoria, South Africa
Unknown Facility
Westdene Johannesburg Gauteng, South Africa
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Luhansk, Ukraine
Unknown Facility
Sumy, Ukraine
Related Publications (1)
Arathoon E, Bhorat A, Silaghi R, Crauwels H, Lavreys L, Tambuyzer L, Vanveggel S, Opsomer M. Week 48 results of a Phase IV trial of etravirine with antiretrovirals other than darunavir/ritonavir in HIV-1-infected treatment-experienced adults. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19783. doi: 10.7448/IAS.17.4.19783. eCollection 2014.
PMID: 25397527DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen R&D Ireland Clinical Trial
Janssen R&D Ireland
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2011
First Posted
August 23, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
October 13, 2014
Record last verified: 2014-10