San Miguel

Researchers are evaluating a phase II, randomized, double-blind, placebo-controlled study involving 48 adults aged 18 to 70 years who have recently been diagnosed with acute HIV infection. The study aims to assess whether adding a combination of HIV-specific broadly neutralizing antibodies (bNAbs) to standard antiretroviral therapy (ART) is safe and whether this combination can delay the return of detectable HIV viral levels, reduce viral reservoirs, and improve HIV-specific immune responses compared to ART with placebo. Participants receive either the combination bNAbs or placebo along with ART at the start of the study. The bNAbs include VRC07-523LS given as a 10 mg/kg intravenous infusion over 15 to 30 minutes and PGT121.414.LS given as a 5 mg/kg intravenous infusion over 30 to 60 minutes, both administered once at entry. ART consists of daily oral tablets containing bictegravir, emtricitabine, and tenofovir alafenamide. The study includes multiple steps: initial treatment with ART and antibody or placebo infusions (Step 1), analytic treatment interruption (ATI) to monitor viral rebound (Step 2 and Step 3), and ART restart when criteria are met (Step 4). Throughout the study, participants undergo regular visits with laboratory tests to monitor HIV viral load, CD4+ T-cell counts, safety labs, and pregnancy tests when applicable. Researchers track the occurrence of significant adverse events related to the study antibodies and measure the time it takes for HIV viral levels to rebound after stopping ART. Participants must adhere to contraceptive requirements and use barrier methods to prevent HIV transmission during ATI. The total study duration includes treatment, interruption, and follow-up phases lasting up to 24 weeks or longer depending on individual progress.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.