Through our research studies, Special Immunology Services have broadly contributed to the field of HIV medicine with a few highlighted areas below:
- Vital pharmacokinetics data for the safe and effective use of antiretroviral drugs used by children with HIV
- Maternal and child health for improved care of women and children living with or exposed to HIV
- Increasing HIV screening in the Emergency Department at Children’s National Hospital
- Understanding perceptions that adolescents and caregivers have regarding pre-exposure prophylaxis against HIV
Special Immunology Services is one of the few pediatric sites that participates in the D.C. Cohort HIV Study, which is a longitudinal research project that collects clinical data from participating people living with HIV in the District of Columbia (DC). The D.C. Cohort is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). The primary goal of this study is to improve the quality of care and treatment of people living with HIV receiving care in our region.
Below is a list of active ongoing, industry-sponsored clinical trials that we are participating in:
- Gilead Protocol 0106 is an open-label study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) within three cohorts:
- Cohort 1: Treatment-naïve adolescents
- Cohort 2: Virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥25 kg
- Cohort 3: Virologically suppressed HIV-1 infected children ≥2 years of age and weighing ≥ 14 to <25 kg
The objectives of this study are to measure pharmacokinetics, safety and tolerability, and antiviral activity. Unique features of this study include a DXA scan. Total trial duration is approximately 48 weeks.
- Gilead Protocol 1474 is an open-label study of Bictegravir/Emtricitabine/Tenofovir/Alafenamide (B/F/TAF) with three cohorts:
- Cohort 1 & 2: adult strength B/F/TAF 50/200/25 mg fixed-dose combination (FDC)
- Cohort 3: low dose B/F/TAF 30/120/15 mg FDC
The objectives of this study are to measure pharmacokinetics, safety and tolerability, and antiviral activity in HIV-1 infected virologically suppressed adolescents and children. Total trial duration is approximately 48 weeks.