A phase 1, first in man, study to assess the safety, pharmacokinetic profile and antiretroviral efficacy of C34-PEG-4-Chol, a novel peptide fusion inhibitor for the treatment of HIV infection

Imperial College London0 sites42 target enrollmentJanuary 29, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Imperial College London
Enrollment: 42
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28842581

Registry

who.int

Start Date

January 29, 2015

End Date

April 1, 2016

Last Updated

7 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Imperial College London

Eligibility Criteria

Inclusion Criteria

•1\. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures, and be willing to comply with all study requirements
•3\. Between 18 to 60 years, inclusive
•4\. Documented HIV\-1 infected for \=6 months from screening
•5\. Comorbidities, if present, optimally managed and stable
•6\. Normal physical examination
•7\. No clinically significant abnormalities on laboratory screening test
•8\. BMI 19\-28, inclusive
•9\. Patients who are heterosexually active must agree to use two effective forms of contraception (e.g., condom with spermicide and established hormonal contraception) during heterosexual intercourse, from screening through to completion of the study
•10\. CD4 count \=400 cells/µL at screening
•11\. Plasma HIV RNA \=10000 copies/mL at screening

Exclusion Criteria

•1\. Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease) disease immunodeficiency disorders, active infection, or malignancy
•2\. Participation in an investigational trial involving administration of any investigational compound within 90 days of screening
•3\. History of alcohol use considered by the investigator to be sufficient to hinder compliance with treatment, follow\-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should be expected to remain consistent throughout the study
•4\. History of recreational drug use within 14 days of screening or a positive drug screen on day of screening
•5\. Any medication taken listed in Section 8\.3 of the protocol (Interaction with other drugs) including over\-the\-counter medications and herbal products, within 28 days of screening with the exception of vitamins and/or paracetamol. When a concomitant medication is necessary this will be reviewed by the investigator and if not contraindicated may be continued
•6\. History of drug sensitivity or drug allergy which in the opinion of the investigator may put the patient at increased risk of drug reactions during the study
•7\. Patients with female partners who are not using 2 effective forms of contraception or with partners who are pregnant
•8\. Documented resistance of clinical relevance to any other class of HIV antiretroviral drugs
•9\. Previous exposure to fusion inhibitors (T20/enfuvirtide)
•10\. Receiving ART within 6 months of screening