Status:
COMPLETED
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
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Human Immunodeficiency Virus Type 1
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of...
Detailed Description
This is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infec...
Eligibility Criteria
Inclusion
- Documented human immunodeficiency virus type 1 (HIV-1) infection for at least 6 months prior to the screening date
- Participant who has not been treated with a therapeutic HIV vaccine within 1 year prior to enrolment and has never been treated with an antiretroviral (ARV) medication indicated for the treatment of HIV infection or ARVs for treatment of hepatitis B-infection with anti-HIV activity
- Participant agrees not to start antiretroviral therapy (ART) before the baseline visit
- Able to comply with the protocol requirements and have good accessible veins
- HIV-1 plasma viral load at screening visit of above 5,000 HIV-1 Ribonucleic acid copies/mL
- CD4+ cell count above 200 cells/mm3 at screening
Exclusion
- HIV-2 infected participants and/or participants with any active or chronic hepato-renal disease
- Life expectancy of less than 6 months
- Documented acute (primary) HIV-1 infection
- Pre-existing protease inhibitor (PI) medication resistance
- Any currently active Acquired Immunodeficiency Syndrome (AIDS) - defining illness
- Any active clinically significant disease or findings during screening or medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study
- Any confirmed grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading scale at screening
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00838162
Start Date
June 1 2009
End Date
February 1 2011
Last Update
June 12 2013
Active Locations (3)
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1
Berlin, Germany
2
Frankfurt, Germany
3
Hamburg, Germany