GS 0110 Open Label Single Tablet Comparison in HIV Patients

• Research type

  Research Study

• Full title

  A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared with a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults

• IRAS ID

  74065

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2010-024007-27

• ISRCTN Number

  not known

• Research summary

  HIV continues to be a major, global medical problem. For initial HIV treatment, guidelines recommend combination therapy with three drugs from two classes: two nucleosides (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), a ritonavir-boosted protease inhibitor, or an integrase inhibitor.Currently, there is only one, once-daily, pill available for HIV treatment, EFV/FTC/TDF (known as Atripla). Side effects are the main reason for changing therapy. New, safe, effective and simple treatments are needed.Rilpivirine (RPV) is a next generation NNRTI. Clinical trials indicate that RPV can be taken once daily, is effective, well-tolerated and safe. A once a day combination pill of rilpivirine plus two NRTIs (FTC and TDF) may provide a well-tolerated option to simplify HIV treatment. This experimental combination pill is known as FTC/RPV/TDF.The purpose of this study is to see if the combination pill FTC/RPV/TDF is safe and effective in reducing levels of HIV-1 in the blood of participants who have not received any treatment for HIV yet, compared with the currently available pill EFV/FTC/TDF.700 patients from 170 sites in North America and Europe will take part. This is an open-label study (you will know which treatment you are receiving) with two treatment arms: Arm 1: FTC/RPV/TDF Arm 2: EFV/FTC/TDFStudy procedures include vital signs, physical examinations, laboratory tests and questionnaires about HIV symptoms, treatment, and side effects experienced during the study. A 35 day screening period is followed by a 96 week treatment period. There are 15 study visits during this time. After Week 96, Arm 1 participants will attend either a 30 day follow-up visit (if FTC/RPV/TDF is commercially available), or a study drug discontinuation visit (if FTC/RPV/TDF is not commercially available). Arm 2 participants will attend a 30 day follow-up visit. The study sponsor is the pharmaceutical company, Gilead Sciences Inc.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  11/LO/0275

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion