Topic: Infectious diseases and microbiology
Conditions
Interventions
1. C34-PEG4-Chol (Peptivir-H), HIV fusion inhibitor
2. Placebo, sodium chloride 0.9% solution
Sponsors
Imperial College London
Eligibility
Sex/Gender
Male
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety, pharmacokinetic & pharmacodynamic (viral decay - stage 2 only) parameters; Timepoint(s): Stage 1 - up to day 84 post-single dose 2. Stage 2 - follow up duration to be determined from stage 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in plasma HIV RNA; Timepoint(s): Stage 1 - measured up to day 28 post-single dose 2. Detailed pharmacokinetic profile of C34-PEG4-Chol when administered at different single doses. Timepoint(s): Stage 1 - profile at day 84 post-single dose 3. Detailed pharmacokinetic profile of C34-PEG4-Chol when administered following multiple dosing; Timepoint(s): Stage 2 - profile at final follow up (duration to be determined from stage 1) 4. Emergence of mutations within heptad repeat-1 (HR-1) region of gp41; Timepoint(s): Stage 2 - measured up to 4th follow up visit (duration of follow up to be determined from stage 1) 5. Listing of all adverse events (grade 1 and above); Timepoint(s): Stage 1-up to day 84 post-single dose Stage 2-up to final follow up (fu determined from stage 1) | — |
Countries
United Kingdom
Outcome results
None listed