TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
Information source: Tibotec Pharmaceutical Limited
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: TMC114/rtv (Drug); TMC114/rtv (Drug); TMC114/rtv (Drug); TMC114/rtv (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Tibotec Pharmaceutical Limited Official(s) and/or principal investigator(s):
Tibotec Clinical Trial, Study Director, Affiliation: Tibotec Pharmaceutical Limited
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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 stuided. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2003
Ending date: November 2007
Last updated: March 6, 2008
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