Publications by authors named "Frank L Tomaka"

Article Synopsis
  • - The study examined the effects of a heterologous Ad26/MVA vaccine on immune responses in people living with HIV-1 who interrupted their antiretroviral treatment.
  • - It was found that while the vaccine primarily produced binding antibodies related to the vaccine strain, these did not correlate with the time it took for the virus to rebound after treatment interruption.
  • - Individuals who experienced delayed viral rebound had significantly higher levels of antibodies that promote phagocytosis (ADCP), suggesting that vaccines generating cross-reactive immune responses could help in controlling the virus after treatment stops.
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Background: Analytic treatment interruption (ATI) studies evaluate strategies to potentially induce remission in people living with HIV-1 but are often limited in sample size. We combined data from four studies that tested three interventions (vorinostat/hydroxychloroquine/maraviroc before ATI, Ad26/MVA vaccination before ATI, and VRC01 antibody infusion during ATI).

Methods: The statistical validity of combining data from these participants was evaluated.

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We administered Ad26, modified vaccinia Ankara vectors containing mosaic HIV-1 antigens or placebo in 26 individuals who initiated antiretroviral therapy during acute human immunodeficiency virus infection as an exploratory study to determine the safety and duration of viremic control after treatment interruption. The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).

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Background: More than 1·8 million new cases of HIV-1 infection were diagnosed worldwide in 2016. No licensed prophylactic HIV-1 vaccine exists. A major limitation to date has been the lack of direct comparability between clinical trials and preclinical studies.

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PIANO (NCT00665847) investigated etravirine pharmacokinetics, efficacy, and safety in children and adolescents. Treatment-experienced, HIV-1-infected patients (≥6 to <18 years) received etravirine 5.2 mg/kg twice daily (maximum 200 mg twice daily) plus background antiretrovirals.

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Background: ARIEL (Darunavir in treatment-experienced pediatric population) was a phase II, open-label study assessing safety and antiviral activity of darunavir/ritonavir twice daily with an optimized background regimen (OBR) in treatment-experienced, HIV-1-infected pediatric patients (3 to <6 years, weighing 10 to <20 kg).

Methods: The study consisted of an initial 4-week screening period, 48 weeks of treatment and a 4-week follow-up period. Patients initially received darunavir/ritonavir 20/3 mg/kg twice-daily for 2 weeks.

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Objectives. TEACH (NCT00896051) was a randomized, open-label, two-arm Phase II trial to investigate the pharmacokinetic interaction between etravirine and atazanavir/ritonavir and safety and efficacy in treatment-experienced, HIV-1-infected patients. Methods.

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Article Synopsis
  • COBI is a selective inhibitor of CYP3A, enhancing the pharmacokinetics of Darunavir (DRV) with fewer drug interactions compared to ritonavir; it was tested in a 48-week study with HIV-infected adults regarding safety and efficacy of the treatment regimen.* -
  • In a cohort of 295 treatment-naive patients, common adverse events included diarrhea (27%) and nausea (23%), while serious adverse events occurred in 7% of patients; only a small percentage discontinued due to adverse effects.* -
  • After 48 weeks, 83% of patients achieved a viral load below 50 c/mL, with a median CD4+ increase of 169 cells/mm³, indicating effective
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Unlabelled: Once-daily darunavir/ritonavir (800/100 mg), plus other antiretrovirals, is recommended for HIV-1-infected patients. Low therapy adherence is linked with poor outcomes. Pill burden can impact adherence.

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The ability to dose antiretroviral agents once daily simplifies the often complex therapeutic regimens required for the successful treatment of HIV infection. Thus, once-daily dosing can lead to improved patient adherence to medication and, consequently, sustained virological suppression and reduction in the risk of emergence of drug resistance. Several trials have evaluated once-daily darunavir/ritonavir in combination with other antiretrovirals (ARTEMIS and ODIN trials) or as monotherapy (MONET, MONOI and PROTEA trials) in HIV-1-infected adults.

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Background: Cobicistat is an alternative pharmacoenhancer to ritonavir. In healthy volunteers, darunavir exposure was comparable when darunavir 800 mg once daily was co-administered with cobicistat 150 mg once daily (as single agents or a fixed-dose combination) vs. with ritonavir 100 mg once daily.

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