ACTRN12612000696897
Completed
Phase 1
A Phase 1, Placebo-Controlled, Randomised Study of the Safety, Pharmacokinetics and Antiviral Activity of BIT225 in Patients with Human ImmunodeficiencyVirus-1 Infection.
Biotron Limited0 sites24 target enrollmentJune 29, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biotron Limited
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or females aged 18 to 65 years.
- •2\. HIV\-1 infection, as documented by a rapid HIV test or any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV\-1 antigen, plasma HIV\-1 RNA, or a second antibody test by a method other than rapid HIV and ELISA is acceptable as an alternative confirmatory test.
- •3\. Antiretroviral therapy naive (defined as no previous ART except if used for pre\- or post\-exposure prophylaxis or women who were administered ART for prevention of mother to child transmission; in all cases, therapy cannot exceed 12 weeks, and there can be no ART in the last 90 days).
- •4\. Plasma HIV\-1 RNA \> 5,000 copies/mL within 30 days before Entry (Day 1\) by any FDA\-approved test for quantifying HIV\-1 RNA at any certified laboratory.
- •5\. CD4\+ count \> 350 cells/mm3 within 30 days before Entry (Day 1\).
- •6\. For women of reproductive potential, negative serum or urine pregnancy test with a sensitivity of \< 25 miU/mL at Screening (baseline) and Day 1\.
- •Females of reproductive potential (defined as women who have not been post\-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation),
- •Subjects 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 and menopause is the woman’s self\-reported history of surgical sterilization, menopause or male partner’s asoospermia. Follicle stimulating hormone\-release factor (FSH) measurement can be used to document menopausal range.
- •7\. All subjects must agree not to participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). If participating in sexual activity that could lead to pregnancy, the subject must agree to use two reliable methods of contraception while receiving study treatment and for 6 weeks after stopping study treatment.
- •Two of the following methods must be used concomitantly :
Exclusion Criteria
- •1\. Currently has any active AIDS defining illness ( according to the CDC Surveillance Case Definition for HIV Infection, AIDS\-Defining Conditions, updated December 5, 2008\.
- •2\. Patients who are expected to need systemic antiviral therapy at any time during their participation in the study.
- •3\. Patients who have received an investigational drug for HIV, HIV vaccine, immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, or other investigational therapy within 30 days prior to study entry.
- •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\. History or other evidence of renal disease.
- •6\. Abnormal hematological and biochemical parameters within 30 days of Entry (Day 1\):
- •a. Absolute neutrophil count \<1000/mm3
- •b. Haemoglobin \<12 g/L in females or \<13 g/L in males
- •c. Platelet count \<75,000/mm3
- •d. Estimated creatinine clearance \< 60 mL/minute. Value will be calculated using the Cockcroft\-Gault formula.
Outcomes
Primary Outcomes
Not specified
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