Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients

Inclusion criteria

• HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (e.g. laboratory report);
• Male and female, age 20 years or older;
• Asymptomatic (generalized lymphadenopathy can be included), defined as subjects without stage 3 defining opportunistic illnesses according to revised Surveillance Case Definition for HIV Infection published in 2014, which was determined by the Investigator based on the medical history, physical examination, ECG, and laboratory evaluations;
• CD4+ (D1) T cell count > 350 cells/mm3 at the Screening Visit;
• HIV-1 viral load > 5,000 copies/mL at the Screening Visit;
• HIV antiretroviral therapy (ART)-naïve i.e., subjects who receive no prior or current HIV antiretroviral drugs;
• Male subjects and female subjects of childbearing potential must agree to use the acceptable method of contraception during the course of the study (excluding women who are not of childbearing potential). Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit; Definitions Women NOT of childbearing potential: women who are permanently or surgically sterilized or postmenopausal. Permanent sterilization includes hysterectomy, and/or bilateral oophorectomy, and/or bilateral salpingectomy and/or tubal ligation.

Postmenopausal women: 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.

Acceptable method of birth control for WOCBP: abstinence; implant; intrauterine device; hormonal contraceptive (injectable, oral contraceptives, transdermal patches, or contraceptive rings) plus barrier method (male condom, female condom or diaphragm).

Acceptable method of birth control for male subjects: abstinence; condom.

• Subjects signed the informed consent before undergoing any study procedures. -

Exclusion criteria

• Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;
• Subjects with acute opportunistic infection(s) or bacterial infection(s), that the delayed initiation of ART would not be allowed, as judged by the Investigator;
• Any stage 3 defining opportunistic illnesses such as Kaposi's sarcoma according to the revised Surveillance Case Definition for HIV Infection published in 2014 within the past 12 months before the Screening Visit;
• Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to the Screening Visit;
• Any previous exposure to a monoclonal antibody within 12 weeks prior to the Screening Visit;
• Any previous hypersensitivity reaction to monoclonal antibody;
• Any significant diseases (other than HIV-1 infection) or clinically significant findings that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy;
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones);
• Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test within 12 weeks prior to the Screening Visit;
• Serum GPT/ALT value is 3 times or greater than the upper limit of normal (≥ 3 xULN) at the Screening Visit;
• Serum GOT/AST value is 3 times or greater than the upper limit of normal (≥ 3 xULN) at the Screening Visit;
• Serum total bilirubin (TBIL) value is 1.5 times or greater than the upper limit of normal (≥1.5 xULN) at the Screening Visit;
• Serum creatinine value is greater than 1.3 times the upper limit of normal (>1.3xULN) at the Screening Visit;
• Any vaccination within 8 weeks prior to the Screening Visit;
• Any treatment with immunomodulators, such as interleukins, interferon, cyclosporine, systemic corticosteroid, or systemic chemotherapy within 12 weeks prior to the Screening Visit; Note: Subjects received short-term low dose oral (i.e. prednisone ≤0.5mg/kg/day for ≤ 1-month duration), inhaled, nasal, or topical steroids will not be excluded.
• Prior participation in any HIV vaccine trial;
• Subjects who have ever received UB-421 IV or SC formulations;
• Receipt of other investigational study agent within 12 weeks before the Screening Visit;
• Life expectancy of less than 12 months;
• Any current alcohol or illicit drug use that, in the Investigator's opinion, would interfere with the subject's ability to comply with the dosing and visit schedules and protocol evaluations.

-