HIV-1 (asymptomatic patients)
Conditions
Interventions
Product Name: BI-201
Product Code: BI-201
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BI-201
Concentration unit: mg
Sponsors
BioInvent International AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 18-65 year old patients of both sexes. 2 Body weight 50-100 kg at screening. 3 HIV-1 seropositive patients. 4 = 6 months following 1st diagnosis of HIV and below 10 years. 5 Plasma viral load more than or equal to 3,000 - less than or equal to 100,000 copies viral RNA/mL. 6 CD4+ cell count more than or equal to 300/mm3 at two occasions measured 3 months apart. 7 No prior antiretroviral therapy within 6 months of screening. 8 No antiviral drug within 8 weeks of screening. Patients stabilized on Aciclovir and Valaciclovir for more than 6 months may be enrolled. 9 Asymptomatic at screening and Day 0 concerning the HIV-infection. 10 Karnofsky performance status of 90% at screening. 11 If positive screen for HBV or HCV, inclusion allowed if patients have no active infection. If positive screen for both HBV and HCV, alanine aminotranferase (ALT) must be within normal range at screening. 12 Be willing and able to comply with the protocol for the duration of the study including scheduled follow-up visits. 13 Have given written informed consent, prior to screening, with the understanding that consent may be withdrawn at any time without prejudice. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Females of childbearing potential must not be enrolled. 2 Other systemic infection than HIV-1 within 6 weeks or vaccination prior to screening or day 0. 3 Autoimmune diseases, Rheumatoid Arthritis or Inflammatory Bowel Disease confirmed by clinical history. 4 Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal at screening. 5 Hemoglobin < 120 g/L (< 110 g/L for women) at screening. 6 Neutrophil counts < 1.0x10-9/L (Africans with a stable count of < 0.6x10-9/L) at screening. 7 Platelet count < 75x10-9/L at screening. 8 Subjects with history or currently active alcohol or drug use which in the Investigator’s opinion, would compromise the subject’s safety and compliance with the study protocol requirements. 9 A positive urine drug screen for opiates, cocaine and amphetamine at two consecutive screenings (a positive drug test at screening will be repeated at baseline). 10 Active cardiovascular treatment. 11 Allergies which could be detrimental according to the Investigator’s opinion. 12 Previous allergic reaction to immunoglobulin. 13 Any disease that might interfere with patient safety or compliance. 14 Participation in a drug study with a new investigational drug within 90 days prior to Day 0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To monitor tolerability after single IV doses and after a short repeat dose regimen with initial loading doses (to achieve a rapid steady state serum level).;Secondary Objective: To determine single dose and repeat dose IV pharmacokinetics. To monitor viraemia after single doses. To determine the dose range associated with a reduction in mean viraemia ³ 0.6 log HIV-1 RNA copies/mL plasma (early Proof of Concept). To monitor duration of any achieved decrease in viraemia. To obtain tolerance data from 4 weeks of repeat dose administration. To apply the loading regimen. To demonstrate the rapid attainment of steady-state. To characterize the serum levels at steady-state. To assess stationarity (i.e. time invariance) after repeat dosing.;Primary end point(s): Drug safety in asymptomatic HIV-1 patients. | — |
Countries
United Kingdom
Outcome results
None listed