Status:
COMPLETED
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Human Immunodeficiency Virus Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
Detailed Description
This is a randomized (the study medication is assigned by chance), active controlled (participants are assigned to either a recognized effective treatment or the study medication) study. This study co...
Eligibility Criteria
Inclusion
- Documented human immunodeficiency virus type 1 (HIV-1) infection
- Never been treated with an antiretroviral (ARV) treatment or therapeutic HIV vaccine, or received less than or equal to 2 weeks treatment prior to screening with an nucleoside reverse transcriptase inhibitors
- HIV-1 plasma viral load above 5000 HIV-1 RNA copies per milliliter, at screening
- Cortisol of at least 550 nano moles per liter (19.9 microgram per deciliter) at screening
- Sensitivity to investigator selected nucleosides, at screening
Exclusion
- Currently having active Acquired Immunodeficiency Syndrome (AIDS) defining illness
- Known or suspected acute (primary) HIV-1 infection
- Any current or history of adrenal disorder, and an acute hepatitis A, B, or C infection
- Documented genotypic evidence of Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) resistance at screening
- Pregnant or breastfeeding females
- Not agree to protocol-defined effective use of contraception
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00110305
Start Date
June 1 2005
End Date
December 1 2011
Last Update
June 25 2014
Active Locations (40)
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1
Beverly Hills, California, United States
2
Washington D.C., District of Columbia, United States
3
Orlando, Florida, United States
4
Tampa, Florida, United States