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.
- Conditions
- Human Immunodeficiency Virus-1 infectionInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12621001354875
- Lead Sponsor
- Biotron Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
1. Males or females aged 18 to 65 years., inclusive.
2. INSTI, NNRTI or non-ritonavir or non cobisistat boosted PI, plus one or two nucleoside/nucleotide agents therapy for >/= 24 months with HIV-1 RNA < 50 copies/mL.
3. Screening plasma HIV-1 RNA < 50 copies/mL.
4. Screening CD4 count =/< 350 cells/mm3, or CD4 count < 500 cells/mm3 with CD4/CD8 ratio =/< 0.6.
5. Females of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, or women who have not undergone surgical sterilization; specifically, hysterectomy, or bilateral oophorectomy and/or tubal ligation), must have a negative serum or urine pregnancy test with a sensitivity of at least 50mlU/mL at Screening and within 24 hours of starting study treatment on Day 1.
6. All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the course of the study.
If participating in sexual activity that could lead to pregnancy, the participant and partner must agree to use two reliable methods of contraception simultaneously while receiving study treatment.
A combination of TWO of the following methods MUST be used appropriately:
Condoms (male or female)
Diaphragm or cervical cap
Intrauterine device (IUD)
Hormonal-based contraception
7. Participants who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives. Acceptable documentation of sterilization, menopause or male partner’s azoospermia must be provided; follicle stimulating hormone-release factor (FSH) measurement can be used to document menopausal range.
8. Negative test for SARS-CoV during the Screening period. If SARS-CoV-2 vaccinated, vaccination regimen must be completed >/= 30 days before screening.
9. Provide written informed consent to participate in the study and be willing to comply with the study procedures.
1. Currently have an active AIDS defining illness (according to the CDC Surveillance Case Definition for HIV infection, AIDS-Defining Conditions, revised April 11, 2014).
2. 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.
3. 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).
4. 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.
5. Confirmed or suspected active TB disease
6. Pregnancy or breastfeeding
7. 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.
8. Screening ECG QTcF value greater than or equal to 450 ms
9. The consumption / administration of concomitant medication (prescribed, over-the-counter or complementary) at the time of the Screening visit.
10. Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements.
11. 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.
12. 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.).
13. History of documented or presumed coronary artery disease, clinically significant cardiovascular disease, or clinically significant arrhythmia.
14. History of a severe seizure disorder, or current anticonvulsant use.
15. 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.
16. 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.
17. Active thyroid disease (use of thyroid hormone replacement therapy permitted, but TSH or free T4 must be in normal range).
18. 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 o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method