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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 Period

Mean 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

Page last updated: August 20, 2015

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