An open-label study of the safety and efficacy of 12 weeks treatment with BIT225 and Combination Antiretroviral Therapy (cART) in patients with Human Immunodeficiency Virus-1 (HIV-1) with only partial immune reconstitution.

Exclusion Criteria28

• Currently have an active AIDS defining illness (according to the CDC Surveillance Case Definition for HIV infection, AIDS-Defining Conditions, revised April 11, 2014).
• Participants currently receiving HIV-1 cART regimen containing ritonavir-boosted or cobicistat boosted protease inhibitor, or therapy for other conditions that include agents with clinically significant drug metabolising enzyme induction properties.
• Participants who have received an investigational drug for HIV-1, HIV 1 vaccine, immunomodulators (e.g. interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, or other investigational therapy within 45 days prior to initiation of the study observation period (Day -28).
• Acute or chronic viral hepatitis as defined by the presence of: 1) anti-HAV IgM Ab; 2) HCV requiring treatment during the course of the study; 3) HBV requiring treatment during the course of the study.
• Confirmed or suspected active TB disease
• Pregnancy or breastfeeding
• 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 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 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 illicit drugs at Screening, during the observation period 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 cancer or suspected cancer or a history of malignancy within 2 years of the initiation of the observation period of the study.
• History of having received any systemic anti-neoplastic or immunomodulatory treatment within 6 months prior to the initiation of the observation period of the study, 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 hospitalisation 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 the initiation of the observation period.
• Known allergy/sensitivity or any hypersensitivity to components of study drug or its formulation.
• Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated observation period of the study.
• Current use of herbal medications or unwillingness to cease use during study participation.