A study of the safety and efficacy of 6 months treatment with BIT225 and Combination Antiretroviral Therapy (cART) in patients with Human Immunodeficiency Virus-1 (HIV-1) compared to cART alone, including measurement of BIT225 in the blood, antiviral activity and immune markers.

Exclusion Criteria30

• Currently have any active AIDS defining illness (according to the CDC Surveillance Case Definition for HIV infection, AIDS-Defining Conditions, revised April 11, 2014).
• Participants who have received an investigational drug for HIV-1, HIV-1 vaccine, immunomodulators, systemic cytotoxic chemotherapy, or other investigational therapy within 45 days prior to study entry (Day 1).
• Participants who have received a SARS-CoV-2 vaccination within the past thirty (30) days prior to screening.
• Acute or chronic viral hepatitis as defined by the presence of: 1) anti-HAV IgM Ab (acute hepatitis A), 2) HCV Ab with a detectable HCV RNA by PCR (acute or chronic hepatitis C) or 3) hepatitis B surface antigen or HBV DNA in subjects with isolated HBcAb, defined as negative HBsAg, negative HBsAb and positive HBcAb (acute or chronic hepatitis B).
• Confirmed or suspected active tuberculosis (TB) disease.
• History or laboratory evidence of clinically significant renal disease.
• Pregnancy or breastfeeding, as well as male partners of pregnant females.
• Abnormal haematological and biochemical parameters at screening (any of the following):
• a. Absolute neutrophil count <1000/mm3
• b. Haemoglobin <10 g/dL in females or less than or equal to 12 g/dL in males
• c. Platelet count <150,000/mm3
• d. International normalised ratio (INR) >1.5
• e. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or alkaline phosphatase greater than or equal to 2.5 times upper limit of normal
• f. Creatinine > 1.5 mg/dL
• g. Estimated creatinine clearance < 60 mL/minute at screening. Value will be calculated using the Cockcroft-Gault formula.
• Screening ECG QTcF value greater than or equal to 450 ms.
• The consumption / administration of concomitant medication (prescribed, over-the-counter or complementary) at the time of the Screening visit.
• Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements.
• A positive result on urine screen for drugs of abuse at Screening or Day 1 which in the opinion of the Investigator should preclude them from participation in the study.
• History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis requiring more than intermittent non-steroidal anti-inflammatory medications for management, etc.)
• History of documented or presumed coronary artery disease, clinically significant cardiovascular disease, or clinically significant arrhythmia.
• History of a severe seizure disorder or current anticonvulsant use.
• Evidence of an active or suspected cancer or a history of malignancy within 2 years of commencement of the study.
• History of having received any systemic anti-neoplastic or immunomodulatory treatment within 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
• Active thyroid disease (use of thyroid hormone replacement therapy permitted but TSH or free T4 must be in normal range.)
• Serious illness requiring systemic treatment and/or hospitalization until the participant either completes therapy or is clinically stable on therapy, in the opinion of the site Investigator, or at least 7 days prior to study entry.
• Known allergy/sensitivity or any hypersensitivity to components of study drug or its formulation.
• Difficulty abstaining from grapefruit, starfruit, and pomelo, including products containing these fruit, from 7 days prior to the first dose of investigational product until the end of the dosing period.
• Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration.
• Current use of herbal medications or unwillingness to cease use during study participation.