ISRCTN89747147已完成1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28842581
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •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
- •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
排除标准
- •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
研究者
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