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
Information source: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus Type 1
Intervention: TMC310911 75 mg twice daily (Drug); TMC310911 150 mg twice daily (Drug); TMC310911 300 mg twice daily (Drug); TMC310911 300 mg once daily (Drug); Ritonavir 100 mg twice daily (Drug); Ritonavir 100 mg once daily (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Tibotec Pharmaceuticals, Ireland Official(s) and/or principal investigator(s): Tibotec Pharmaceuticals, Ireland Clinical Trial, Study Director, Affiliation: Tibotec Pharmaceuticals, Ireland
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 TMC310911 co-administered with ritonavir.
Clinical Details
Official title: A Phase IIa, Open-label, Randomized Trial in Treatment-naive HIV-1-infected Subjects to Determine the Antiviral Activity of 14 Days of Monotherapy With 4 Different Dose Regimens of TMC310911 Coadministered With Ritonavir
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)
Secondary outcome: Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment PeriodMean Changes From Baseline in CD4+ Cell Count Maximum Plasma Concentration (Cmax) of TMC310911 Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911 Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing Predose Plasma Concentration (C0h) of TMC310911 Average Steady-state Plasma Concentration (Css,av) of TMC310911 Fluctuation Index of TMC310911
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)-infected participants (participants who had not been treated with a
therapeutic HIV vaccine within 1 year prior to enrollment and who had 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 prior to screening). In this
study approximately 32 participants will be enrolled and randomly assigned to receive 4
different dose regimens co-administered with ritonavir (8 participants in each dosing
regimen). The trial will consist of a screening period (maximum 6 weeks), a treatment
period with TMC310911 (2 weeks), and a follow-up period (4 weeks). Safety evaluation will
include assessment of adverse events, clinical laboratory tests, vital sign measurements,
physical examinations and electrocardiograms.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Berlin, Germany
Frankfurt, Germany
Hamburg, Germany
Additional Information
Starting date: June 2009
Last updated: June 3, 2013
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