C34-PEG-4-Chol - a new fusion inhibitor for the treatment of HIV

Phase 1

Completed

• Conditions: Topic: Infectious diseases and microbiology; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN89747147
• Lead Sponsor: Imperial College London

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-29
• Study Completion: 2016-04-01
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 42

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
2. Male
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
12. In the opinion of the investigator not likely to require ART in the next 4 months
13. No clinically significant abnormalities on 12-lead ECG

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified