Clinical trial

Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir…

NCT00460746 · Tibotec, Inc, Industry · Completed

Key facts

NCT number NCT00460746
Title Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
Official title Open Label Phase 3b, 48 wk Pilot Study of the Antiviral Efficacy and Tolerability of Combination of PREZISTA/r and TMC125 When Substituted for Enfuvirtide, Current Protease Inhibitor(s) and NNRTI(s) in Antiretroviral Resistant Patients With Viral Suppression But Who Are Intolerant of Enfuvirtide.
Lead sponsor Tibotec, Inc, Industry
Collaborators Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions HIV
Intervention type Drug
Interventions TMC125, Darunavir, Ritonavir
Enrollment 10
Start date May 1, 2007
Primary completion Oct 1, 2008
Completion Oct 1, 2008
First posted Apr 16, 2007
Last update posted Jul 31, 2013
Countries United States

At a glance

  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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