C34-PEG4-Chol - a new fusion inhibitor for the treatment of HIV

• Research type

  Research Study

• Full title

  A Phase 1, first in man, study to assess the safety, pharmacokinetic profile and antiretroviral efficacy of C34-PEG4-Chol, a novel peptide fusion inhibitor for the treatment of HIV-infection.

• IRAS ID

  141353

• Contact name

  Alan Winston

• Contact email

  a.winston@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Eudract number

  2014-002671-28

• Duration of Study in the UK

  1 years, 1 months, 0 days

• Research summary

  C34-PEG4-Chol is a new drug developed to treat HIV. It has never been given to humans so a study is needed to check if it is safe. The two stage study is funded by the Medical Research Council and will take place at a single hospital trust.

  Due to reductions in HIV-associated illnesses and death since the advent of combination antiretroviral therapy, HIV-positive people are ageing. This poses new problems such as heart, kidney, bone and liver diseases which, although associated with ageing, may be more widespread due to the long-term side-effects of anti-HIV drugs. Additionally, drug-drug interactions become increasingly frequent and more complex when treating people who are on treatment for other problems. Therefore developing new anti-HIV drugs, with less toxicity and likelihood for interactions, is critical.

  C34-PEG4-Chol belongs to a family of anti-HIV medications called "fusion inhibitors". C34-PEG4-Chol is similar to another drug in this family called enfuvirtide. Due to how it is broken down by the body enfurvitide shows little general toxicity and few drug interactions. However it requires injection under the skin twice daily and injection site reactions are common. C34-PEG4-Chol is expected to need injecting less frequently resulting in fewer reactions.

  Eligible participants:
  • HIV-positive men
  • Not receiving anti-HIV drugs
  • CD4 count (an indicator of immune system strength) above 400 cells
  • HIV viral load (the amount of virus in the blood) above 10000 copies

  Participants will be randomly assigned to C34-PEG4-Chol or placebo and samples collected at various time points. Stage 1 involves giving a single dose, allowing us to work out the best dose and how often to give it. Stage 2 involves giving 4 doses then checking how much drug gets into the bloodstream and how much the HIV level drops. We currently expect that each stage will take about 6 months to complete.

• REC name

  London - Central Research Ethics Committee

• REC reference

  14/LO/2078

• Date of REC Opinion

  24 Dec 2014

• REC opinion

  Further Information Favourable Opinion