GS 0106 Open Label FTC/RPV/TDF fixed-dose in HIV patients

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV 1 Infected Patients

• IRAS ID

  66521

• Contact name

  Brian Gazzard

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2010-023178-37

• ISRCTN Number

  not known

• Research summary

  HIV continues to be a major, global medical problem. Guidelines recommend three drugs from two classes for initial HIV treatment: two nucleosides (NRTIs) with either a non-nucleoside (NNRTI) reverse transcriptase inhibitor or a ritonavir-boosted protease inhibitor. To date, there is only one highly effective, once-daily, fixed dose combination tablet for HIV treatment (EFV/FTC/TDF). Side effects are the main reason for changing therapy. New safe and effective treatments are needed. Rilpivirine (RPV) is a next generation NNRTI. Results of animal studies have shown RPV to be safe during pregnancy. Clinical trials indicate that RPV combines a once-daily dosing regimen with potent antiviral effects that is safe and well-tolerated. A fixed dose regimen of rilpivirine plus two NRTIs (FTC and TDF) may provide a well-tolerated option to simplify antiretroviral therapy. This experimental combination pill is known as FTC/RPV/TDF. The purpose of this study is to see if HIV patients taking a ritonavir-boosted protease inhibitor and two NRTIs can safely switch to the FTC/RPV/TDF without increasing the amount of virus in their blood. 420 patients will take part from 115 sites in North America and Europe. This is an open-label study with two treatment arms: Arm 1: participant'switch to FTC/RPV/TDF Arm 2: delayed switch to FTC/RPV/TDF after 24 weeks of staying on their current antiretroviral regimen (ritonavir-boosted protease inhibitor and two NRTIs) Study procedures include vital signs, physical examinations, laboratory tests and questionnaires about HIV symptoms, treatment, and side effects experienced during the study. A 30 day screening period is followed by a study treatment period of at least 48 weeks. For Arm 1 there are at least 9 study visits, and 10 visits for Arm 2. After Week 48, participants may continue to receive FTC/RPV/TDF and attend 12 weekly visits until FTC/RPV/TDF becomes commercially available or the Sponsor, Gilead Sciences, stops its development.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/157

• Date of REC Opinion

  4 Feb 2011

• REC opinion

  Further Information Favourable Opinion