TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1

Summary

This is a 48-week study to compare TNX-355 plus OBT to placebo plus OBT in HIV subjects. You must have a stable viral load of at least 10,000 copies/ml, been treated with highly active antiretroviral therapy (HAART) for at least 6 months, be triple class experienced, and presently failing or have failed a HAART regimen. Subjects will receive infusions every week for 8 weeks, then every two weeks.

Timeline

Start

2004-03

Primary completion

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Completion

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Publications

• Gathe JC, Hardwicke RL, Garcia F, Weinheimer S, Lewis ST, Cash RB. Efficacy, Pharmacokinetics, and Safety Over 48 Weeks With Ibalizumab-Based Therapy in Treatment-Experienced Adults Infected With HIV-1: A Phase 2a Study. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):482-489. doi: 10.1097/QAI.0000000000002591.

Drugs

Indications