UNC PrEP Study: DISCOVER

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infection.

 

Study Name

 

Gilead “DISCOVER Study”

Full title

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infection.

Purpose

To assess the effectiveness of F/TAF (Descovy) at preventing HIV infection.

 

Study Duration

2-4 years

Study Design

Step one:

  • Arm A: Oral Descovy and Truvada placebo
  • Arm B: Oral Descovy placebo and oral Truvada

Step two:

  • Open-label oral Descovy

 

 

Screen, Entry, Week 4, Week 12 and then visits take place every 12 weeks (wk. 24, wk. 36, etc.).

 

Side effects

  • Descovy: Depression, vomiting, abnormal dreams, cough, diarrhea, dizziness, nausea, weakness, fever, headache, fatigue, rash, and stomach cramps.
  • Truvada: Stomach discomfort, abdominal pain, weakness, dizziness, depression, headaches, shortness of breath, increased cough, and runny nose.

Major inclusion criteria

  • Men and transgender women 18 years and older
  • Engaged in/exhibited any of the following:
  • Condomless anal intercourse with at least two unique male partners of unknown/HIV positive status in the last 12 weeks (3 months)
  • Diagnosis of rectal gonorrhea or chlamydia in the last 24 weeks
  • Diagnosis of syphilis in the last 24 weeks (6 months)

 

Major exclusion criteria

History of osteoporosis/bone fragility, use of defibrillator or pacemaker, HIV positive, co-enrollment in study for HIV prevention agents, liver or kidney abnormalities

 

Payment

$50/visit

Location

Chapel Hill, Raleigh (Blue Ridge & Wake), and Durham (Blue City Business Center)

Primary investigator

David Wohl, MD

Contact Information:

1-877-643-9040