ICTUImperial Clinical Trials Unit

Welcome to Imperial Clinical Trials Unit (ICTU)

This website is intended for commercial trial sponsors engaged in the area of pharmaceuticals, medical devices or diagnostic devices

Clinical Trials Search


CurrentAll Trials


Trial Details

  • Trial statusCompleted
  • Chief InvestigatorAlan Winston
  • Project managerNicki Doyle
  • SponsorImperial College London
  • ISRCTN number89747147
  • Phase1

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

Design and Objective

Design: Phase 1 (two stage), first in man, double-blind, randomised, placebo-controlled, single centre study Objectives: • To assess the safety, pharmacokinetics and pharmacodynamics of C34-PEG4-Chol in HIV-positive individuals. • To determine the optimal dose and dosing schedule for C34-PEG4-Chol.

Key inclusion criteria

1. Male 18 to 60 yrs 2. Documented HIV-1 infected with no clinical evidence of seroconversion within 3 months of screening 3. Comorbidities, if present, optimally managed and stable 4. Normal physical examination 5. No clinically significant abnormalities on laboratory screening test or ECG 6. BMI 18-30 7. Effective contraception

Study Disclaimer Statement