Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men
Condition: HIV Prevention; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV
      in order to try and prevent an exposure from becoming an infection is common. This is called
      nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related
      to intrinsic qualities of the drugs used which includes at which point in the life cycle of
      the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated
      the drugs are i.e. what side effects they produce. Many people skip doses during their
      treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir
      works early in the life cycle of the virus i.e. before it integrates with human DNA, is
      potent against HIV and causes few side effects. These qualities make it an obvious choice for
      use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along
      with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible
      sexual exposure to HIV. They will be monitored closely for adverse events, side effects and
      for their ability to take the medicine each day for the whole 28 days. The hypothesis in this
      study states that raltegravir use in NPEP will be safe, well tolerated and result in a high
      treatment completion rate.
    

Detailed description: 
      This is a single site, 72-week, prospective, open-label, non-randomized trial. One hundred
      and 50 (150) eligible participants will be assigned to receive RAL 400 mg BID along with
      tenofovir disoproxil fumarate/emtricitabine (TVD) 1 tablet once daily (3-drug NPEP) for
      28-days or TVD 1 tablet once daily (2-drug NPEP) for 28-days according to established
      Australian guidelines for the use of 3 or 2-drug NPEP following a potential or actual sexual
      exposure to HIV in men who have sex with men (MSM).1 Based on hospital NPEP data over the
      past 2 years, it is anticipated that 100 MSM will receive 3-drug (RAL-TVD) NPEP and 50 will
      receive 2-drug (TVD) NPEP. Follow-up post NPEP is for 23 weeks i.e. to week 24 post exposure.

      Primary study objectives:

      To describe the safety of 28 days of nonoccupational post-exposure prophylaxis(NPEP)
      containing raltegravir (RAL) To describe the tolerability of 28 days of NPEP containing RAL
      To describe on-drug adherence and regimen completion rates of 28 days of NPEP containing RAL

      Secondary study objectives:

      To investigate whether or not receipt of NPEP decreases, increases or has no impact on HIV
      risk taking behaviour To describe the effects of RAL and tenofovir disoproxil
      fumarate/emtricitabine (TVD) on key inflammatory biomarkers in a subset of the main study
      population
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): Drug: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 28 days along with Tenofovir disoproxil fumarate/emtricitabine 300mg/200mg 1 tablet taken orally once daily with or without food for 28 days.
Arms: Raltegravir/Truvada Other Names: Isentress/Truvada
Other intervention name(s): Isentress; Tenofovir disoproxil fumarate/emtricitabine
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; nonoccupational; postexposure; prophylaxis; HIV Seronegativity