About The Study
The purpose of this Phase II (early stage) study is to determine the safety and efficacy of the entry inhibitor TNX-355. The study will compare different doses of TNX-355 in combination with optimized background therapy (OBT) to placebo plus OBT in HIV-positive people. Participants must have a stable viral load of at least 10,000 copies/ml, been treated with highly active antiretroviral therapy (HAART) for at least six months, been exposed to each of the three standard classes of antiretroviral therapy (ART), and be on a failing HAART regimen or have discontinued a failing HAART regimen. Participants will receive intravenous infusions of either TNX-355 or placebo every week for eight weeks, then every two weeks. The study will enroll 80 participants and run for 144 weeks.
The optimized background therapy will be based on medication history and the results of virus sensitivity testing. The OBT may include drugs prescribed under expanded access; however, fusion/entry inhibitors will not be permitted as part of the therapy.
Volunteers will be randomly assigned through a double-blinded process to the following study groups:
* Group A: alternating intravenous infusions of TNX-355 (15mg/kg) and of placebo weekly for the first nine doses (through the Week 8 visit), and then intravenous infusions of TNX-355 (15mg/kg) every two weeks;
* Group B: intravenous infusions of TNX-355 (10mg/kg) weekly for the first nine doses (through the Week 8 visit), and then intravenous infusions of TNX-355 (10 mg/kg) every two weeks;
* Group C: intravenous infusions of placebo weekly for the first nine doses (through the Week 8 visit), and then intravenous infusions of placebo every two weeks.
Study Approach
TNX-355 is one of a new class of experimental drugs called viral entry inhibitors that represent a potential treatment approach to HIV that has become resistant to standard antiviral therapies. TNX-355 targets the CD4 receptor, a molecule found on the surface of CD4 cells. HIV uses the CD4 receptor to attach to and infect a CD4 cell. TNX-355 binds to the CD4 receptor, preventing HIV from entering and infecting the cell.
Results
This trial is listed on Clinicaltrials.gov