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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00071097
First received: October 10, 2003
Last updated: September 19, 2016
Last verified: September 2016

October 10, 2003
September 19, 2016
October 2003
February 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00071097 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
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.
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: TMC114/rtv
    800mg TMC114/100mg rtv once daily
  • Drug: TMC114/rtv
    400mg TMC114/100mg rtv both twice daily
  • Drug: TMC114/rtv
    400mg TMC114/100mg rtv once daily
  • Drug: TMC114/rtv
    600mg TMC114/100mg rtv twice daily
  • Experimental: 001
    TMC114/rtv 400mg TMC114/100mg rtv once daily
    Intervention: Drug: TMC114/rtv
  • No Intervention: 005
    Control Group Control Group, no intervention
  • Experimental: 004
    TMC114/rtv 600mg TMC114/100mg rtv twice daily
    Intervention: Drug: TMC114/rtv
  • Experimental: 003
    TMC114/rtv 400mg TMC114/100mg rtv both twice daily
    Intervention: Drug: TMC114/rtv
  • Experimental: 002
    TMC114/rtv 800mg TMC114/100mg rtv once daily
    Intervention: Drug: TMC114/rtv

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
November 2007
February 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina
Puerto Rico
 
NCT00071097
CR006778, TMC114-C202
Yes
Not Provided
Not Provided
Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceuticals, Ireland
Not Provided
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
Tibotec Pharmaceuticals, Ireland
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP