A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients

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；
• Patients who have previous history of pancreatitis；
• Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required;
• Allergic constitution or known allergy to the components of study drug；
• With a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day)；
• With a history of alcohol abuse within 12 months before screening (average drinking≥14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits, or 150mL wine) or those who have a positive alcohol breath test before enrollment；
• With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment；
• Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine）；
• Other factors that the investigators consider unsuitable for the trial.