Phase 3 of Two Single tablet regimens in HIV-1 Positive Adults

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Positive, Antiretroviral Treatment- Naïve Adults

• IRAS ID

  127907

• Contact name

  Clarke

• Contact email

  Amanda.Clarke@bsuh.nhs.uk

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2013-000102-37

• Clinicaltrials.gov Identifier

  NCT01797445

• Research summary

  The treatment of HIV infection requires the combination of several medications in order to decrease the amount of virus in the body, improve immune function and delay the progression of the disease. This has generally required patients to take a large number of pills each day, and many experience a loss of effectiveness of their current medication regimen over time or unacceptable side effects. Therefore, it is important to develop new drug regimens. In addition, the combination of drugs into a single tablet reduces the number of pills a patient has to take and makes it more convenient to stick to the prescribed drug regimen.

  The experimental drug Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF STR) is being developed by Gilead Sciences, Inc. and has been previously tested in humans.

  The purpose of this study is to evaluate whether E/C/F/TAF STR is safe and effective against HIV-1 in subjects not currently receiving treatment for their chronic HIV-1 infection (except the use for PREP (pre exposure prophylaxis) or PEP (post-exposure prophylaxis), up to 6 months prior to screening), compared to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (E/C/F/TDF STR).

  About 840 participants from approximately 250 sites worldwide will be recruited into this study. Approximately 50 participants will be recruited in the UK.

  Taking part in this study will last about 100 weeks including the screening visit. During this time, participants will be required to visit the clinic at least 14 times.
  Participants will be randomly selected by chance to receive one of two treatments:
  Study Treatment Group 1: Single tablet regimen of E/C/F/TAF + placebo-to-match E/C/F/TDF once daily: 420 subjects
  Study Treatment Group 2: Single tablet regimen of E/C/F/TDF + placebo-to-match E/C/F/TAF once daily: 420 subjects

  The study is made up of the following parts:
  •Screening: One or more visits to the Study Doctor. The screening may last up to 30 days before the study drug is given.
  •Treatment Phase: Daily intake of two tablets (1 active and 1 placebo) for approximately 96 weeks.
  •Post treatment visits every 12 weeks until treatment is unblinded
  •Follow-up: One visit to the Study Doctor 30 days following the unblinding visit.
  Procedures included: medical history, physical examination, vital signs, urine tests, blood tests, ECG, DEXA scan and patient questionnaire.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  13/LO/0574

• Date of REC Opinion

  24 Jun 2013

• REC opinion

  Further Information Favourable Opinion