A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Pa… (NCT04592315) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
China46 participantsStarted 2021-01-23
Plain-language summary
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female aged from 18 to 60 (include 18 and 60)；
✓. Body mass index (BMI) \[weight (kg)/ height 2(m2)\] is from 18.0 to 26.0（include 18.0 and 26.0），male weight≥50kg，female weight≥45kg；
✓. Confirmed HIV-1 infection；
✓. HIV viral load ≥ 1000 copies/mL；
✓. Patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period；
✓. Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document.
Exclusion criteria
✕. Patients in the acute infection stage;
✕. Confirmed AIDS patients；
✕. Patients who have received antiviral therapy and/or have been vaccinated against HIV；
✕. HBsAg is (+), and/or anti-HCV is (+)；
✕. Abnormal liver function tests (ALT and / or AST\> 3ULN, or total bilirubin\> 2ULN)；
✕. Glomerular filtration rate \<70mL/min/1.73m2, or creatinine ≥ULN；
✕. Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases；
What they're measuring
1
Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0