Approved Medications Research

Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial.

HIV Prevention Trials Network study 077 (HPTN 077) evaluated the safety, tolerability, and pharmacokinetics of CAB LA in HIV-uninfected males and females at 8 sites in Brazil, Malawi, South Africa, and the United States.

Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. Read More »

Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial.

This study aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection.

Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial. Read More »

Ibalizumab

Ibalizumab has demonstrated both safety and efficacy in the treatment of HIV-1 infection. Its primary use will be in the setting of multidrug resistant virus as part of combination antiretroviral therapy. Further enhancements of ibalizumab to prolong its clearance and broaden its activity are in development.

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Multidrug Resistant HIV Drug Lauded, But Clinical Foundation Not Very Deep.

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor, indicated for use with other antiretroviral inhibitors in adults with multidrug resistant HIV-1 infection who aren’t responding to their antiretroviral regimen. It is considered an advance. But FDA approval was based on a study of only 40 people-and it had no control group.

Multidrug Resistant HIV Drug Lauded, But Clinical Foundation Not Very Deep. Read More »

Ibalizumab: First Global Approval

TaiMed Biologics is developing ibalizumab (Trogarzo™, ibalizumab-uiyk)—a humanised IgG4 monoclonal antibody—as a treatment for HIV-1 infection. Ibalizumab blocks HIV entry into CD4 cells while preserving normal immunological function and is the first CD4-directed post-attachment HIV-1 inhibitor and the first humanised monoclonal antibody for the treatment of HIV/AIDS. This article summarizes the milestones in the development

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FDA approves novel biologic for resistant HIV infection

During a March 6 conference call for investors, Theratechnologies touted ibalizumab-uiyk as the first antiretroviral in its class, the first FDA-approved HIV-1 specific biological product, and the first HIV treatment that does not require daily administration. Officials said that the company was finalizing its pharmacy distribution network and expected the product to be available within

FDA approves novel biologic for resistant HIV infection Read More »

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