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C34

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

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