NCT00071097

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-10-01
• Primary completion: 2005-02-01
• Completion: 2007-11-01
• First posted: 2003-10-15
• Last updated: 2016-09-20

Locations

39 sites across 2 countries: United States, Argentina