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TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients

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ClinicalTrials.gov Identifier: NCT00071097
Recruitment Status : Completed
First Posted : October 15, 2003
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Description
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Brief Summary:
The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: TMC114/rtv Phase 2

Detailed Description:
A phase II randomized, controlled, partially blinded, trial to investigate dose response of TMC114/RTV in HIV-1 infected patients who have previously received all three licensed classes of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate. Four doses of TMC-114/ritonavir will be studied. 300 patients in the United States and Puerto Rico will participate. The duration of the study is 96 weeks. Randomize to one of 4 treatment groups (TMC114/RTV: 400/100 mg qd; 800/100mg qd; 400/100mg bid; 600/100 bid) or control arm for 24 to 48 wks. Optimal dose (TMC114/RTV 600/100mg bid) open label portion of the study. The trial was extended to include 144Wks of treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose Response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.
Study Start Date : October 2003
Actual Primary Completion Date : February 2005
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 001
TMC114/rtv 400mg TMC114/100mg rtv once daily
 Drug: TMC114/rtv
400mg TMC114/100mg rtv once daily
No Intervention: 005
Control Group Control Group, no intervention
Experimental: 004
TMC114/rtv 600mg TMC114/100mg rtv twice daily
 Drug: TMC114/rtv
600mg TMC114/100mg rtv twice daily
Experimental: 003
TMC114/rtv 400mg TMC114/100mg rtv both twice daily
 Drug: TMC114/rtv
400mg TMC114/100mg rtv both twice daily
Experimental: 002
TMC114/rtv 800mg TMC114/100mg rtv once daily
 Drug: TMC114/rtv
800mg TMC114/100mg rtv once daily


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the dose-response relationship of antiviral activity of the TMC114/RTV dose regimens at 24 Wks in order to determine the optimal dose. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. To evaluate safety and tolerability over 24 to 144Wks; The durability of the antiviral activity; The effect of functional monotherapy with TMC114 over 2 weeks in different doses; and The dose-response by comparing the different TMC114/RTV dosages. [ Time Frame: 144 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age 18 years or older
  • Documented HIV-1 infection
  • Stable PI regimen for at least 8 weeks prior to screening
  • Plasma viral load at screening above 1000 HIV-1 RNA copies/ml
  • Prior use of more than 1 NRTI for at least 3 months
  • Prior use of one or more NNRTIs as part of a failing regimen
  • At least 1 primary PI mutation as defined by the IAS guidelines
  • Treatment with at least 1 PI for a total of at least 3 months
  • Patient has given informed consent

Exclusion Criteria:

  • Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection
  • Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
  • NNRTI as part of therapy at screening
  • Patients on a treatment interruption at screening
  • Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening
  • Hepatitis A, B, or C.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071097


  Show 40 Study Locations
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00071097     History of Changes
Obsolete Identifiers: NCT00980928
Other Study ID Numbers: CR006778
TMC114-C202
First Posted: October 15, 2003    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Tibotec Pharmaceuticals, Ireland:
HIV
TMC114
Ritonavir
 Tolerability
Safety and efficacy
TMC114-C211

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Darunavir
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors