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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071097
• Other study ID #: CR006778
• Secondary ID: TMC114-C202
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2003
• Last updated: September 19, 2016
• Start date: October 2003
• Est. completion date: November 2007

Study information

• Verified date: September 2016
• Source: Tibotec Pharmaceuticals, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIreland: Irish Agriculture and Food Development Authority
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00980928

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 2007
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• TMC114/rtv
800mg TMC114/100mg rtv once daily
• TMC114/rtv
400mg TMC114/100mg rtv both twice daily
• TMC114/rtv
400mg TMC114/100mg rtv once daily
• TMC114/rtv
600mg TMC114/100mg rtv twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tibotec Pharmaceuticals, Ireland

Countries where clinical trial is conducted

United States,  Argentina, 

References & Publications (1)

Clotet B, Bellos N, Molina JM, Cooper D, Goffard JC, Lazzarin A, Wöhrmann A, Katlama C, Wilkin T, Haubrich R, Cohen C, Farthing C, Jayaweera D, Markowitz M, Ruane P, Spinosa-Guzman S, Lefebvre E; POWER 1 and 2 study groups. Efficacy and safety of darunavi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 weeks	No
Secondary	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.		144 weeks	No