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.
- Conditions
- Human Immunodeficiency Virus-1 infectionInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12621000937819
- Lead Sponsor
- Biotron Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 27
1. Males or females aged 18 to 65 years.
2. HIV-1 infection, as documented by rapid HIV-1 test or any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 antigen, plasma RNA, or a second antibody test by a method other than rapid HIV-1 and ELISA is acceptable as an alternative confirmatory test.
3. Individuals initiating the standarised cART regimen (defined as DTG plus TDF and FTC once daily).
4. Antiretroviral therapy naive (defined as no previous cART except if used for pre- or post-exposure prophylaxis, or women who were administered cART for prevention of mother to child transmission; in all cases, prior cART therapy cannot have exceeded 12 weeks in duration; no cART use is permitted within the last 45 days prior to screening).
5. Plasma HIV-1 RNA > 5,000 copies/mL at screening by any FDA-approved test for quantifying HIV-1 RNA (to < 50 copies/mL).
6. CD4+ count >/= 50 cells/mm3 and =/< 350 cells/mm3 at Screening.
7. Negative test for SARS-CoV-2 during screening period.
8. 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.
9. 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) with or without a spermicidal agent
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Hormonal-based contraception
10. 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.
11. Provide written informed consent to participate in the study and be willing to comply with the study procedures.
1. Currently have any active AIDS defining illness (according to the CDC Surveillance Case Definition for HIV infection, AIDS-Defining Conditions, revised April 11, 2014).
2. 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).
3. Participants who have received a SARS-CoV-2 vaccination within the past thirty (30) days prior to screening.
4. 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).
5. Confirmed or suspected active tuberculosis (TB) disease.
6. History or laboratory evidence of clinically significant renal disease.
7. Pregnancy or breastfeeding, as well as male partners of pregnant females.
8. 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.
9. Screening ECG QTcF value greater than or equal to 450 ms.
10. The consumption / administration of concomitant medication (prescribed, over-the-counter or complementary) at the time of the Screening visit.
11. Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements.
12. 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.
13. 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.)
14. History of documented or presumed coronary artery disease, clinically significant cardiovascular disease, or clinically significant arrhythmia.
15. History of a severe seizure disorder or current anticonvulsant use.
16. Evidence of an active or suspected cancer or a history of malignancy within 2 years of commencement of the study.
17. 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.
18. Active thyroid disease (use of thyroid hormone replacement therapy permitted but TSH or free T4 must be in normal range.)
19. 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.
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method