A double blind, phase I/II, randomized, single and repeat dose, dose escalation study of the antibody BI-201 directed against Tat, given IV, versus Placebo in asymptomatic HIV-1 patients. - Double-blind, phase I/II dose-escalation study of BI-201
- Conditions
- HIV-1 (asymptomatic patients)
- Registration Number
- EUCTR2005-001019-23-GB
- Lead Sponsor
- BioInvent International AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
118-65 year old patients of both sexes.
2Body weight 50-100 kg at screening.
3HIV-1 seropositive patients.
4= 6 months following 1st diagnosis of HIV and below 10 years.
5Plasma viral load more than or equal to 3,000 - less than or equal to 100,000 copies viral RNA/mL.
6CD4+ cell count more than or equal to 300/mm3 at two occasions measured 3 months apart.
7No prior antiretroviral therapy within 6 months of screening.
8No antiviral drug within 8 weeks of screening. Patients stabilized on Aciclovir and Valaciclovir for more than 6 months may be enrolled.
9Asymptomatic at screening and Day 0 concerning the HIV-infection.
10Karnofsky performance status of 90% at screening.
11If 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.
12Be willing and able to comply with the protocol for the duration of the study including scheduled follow-up visits.
13Have given written informed consent, prior to screening, with the understanding that consent may be withdrawn at any time without prejudice.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
1Females of childbearing potential must not be enrolled.
2Other systemic infection than HIV-1 within 6 weeks or vaccination prior to screening or day 0.
3Autoimmune diseases, Rheumatoid Arthritis or Inflammatory Bowel Disease confirmed by clinical history.
4Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal at screening.
5Hemoglobin < 120 g/L (< 110 g/L for women) at screening.
6Neutrophil counts < 1.0x10-9/L (Africans with a stable count of < 0.6x10-9/L) at screening.
7Platelet count < 75x10-9/L at screening.
8Subjects 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.
9A positive urine drug screen for opiates, cocaine and amphetamine at two consecutive screenings (a positive drug test at screening will be repeated at baseline).
10Active cardiovascular treatment.
11Allergies which could be detrimental according to the Investigator’s opinion.
12Previous allergic reaction to immunoglobulin.
13Any disease that might interfere with patient safety or compliance.
14Participation in a drug study with a new investigational drug within 90 days prior to Day 0.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method