Cardiovascular Risk in HIV Patients Switching From a Boosted Protease Inhibitor (PI) to Dolutegravir (DTG)
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the benefits of switching away from a kind of drug
      called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients'
      cardiovascular health (the health of their hearts). Patients are currently taking two other
      anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their
      boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the
      boosted PI and dolutegravir more accurately, half of study participants will be switched to
      dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on
      the boosted PI.

      Boosted PIs are associated with increased heart and circulation risk so it is hoped that
      switching from a boosted PI to dolutegravir will improve the health of the patients' hearts.
      Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in
      the US and Europe. Clinical trials using dolutegravir have found that it is effective at
      suppressing the HIV virus, and it is at least as effective as the other drugs.

      This study will also investigate the safety (in terms of other side effects and the routine
      blood tests which the investigators ordinarily use to monitor patients' treatment) and
      monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment
      from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in
      their blood, and CD4 count is a measure of a type of cell that is in their immune system. We
      also aim to improve patients' cardiovascular health in general by providing them with
      information on how to live a healthy lifestyle (eg improving their diet, stopping smoking
      etc).
    

Detailed description: 
      Study Design: Randomised, non-inferiority strategic trial over 96 weeks with early or delayed
      switch from an ARV regimen containing a boosted PI plus 2 NRTIs to dolutegravir (DTG) plus 2
      NRTIs in patients having achieved complete virological suppression for more than 24 weeks
      (HIV-1 RNA <50 c/ml). Patients will be randomised to switch at baseline or at 48 weeks.

      Study visits will take place at screening, baseline, weeks 4 (immediate switch group only),
      12, 24, 36, 48, 52 (deferred switch group only), 60, 72, 84 and 96, plus a follow up visit 28
      days after the last dose of study medication.

      Routine investigations will include viral load, CD4, haematology (including haemoglobin,
      white cell count and differential, platelets), biochemistry (including sodium, potassium,
      creatinine, albumin, glucose, ALT, ALP, total bilirubin, total cholesterol, HDL, LDL,
      triglycerides), quality of life questionnaires (EuroQL), urine sample (for haematuria,
      proteinuria, glycosuria, leukocytes, nitrate & pregnancy test in WOCBP)
    

Intervention name(s): Dolutegravir
Intervention type(s): Drug
Intervention description(s): Dolutegravir 50mg once daily
Other intervention name(s): Tivicay
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV