Open-Label, Single-Arm, Phase 3B Study of the Incidence of Severe COVID-19 and Adverse Events Following AZD1222 COVID-19 Vaccination in Botswana Against SARS-CoV-2

Primary Objectives:

  • To assess occurrence of severe COVID-19 disease among individuals vaccinated with two doses of AZD1222.
  • To assess adverse events (AEs) among individuals vaccinated with at least one dose AZD1222 overall and by age group, comorbidity group, number of vaccine doses, and the time since the first or second dose.

Secondary Objectives:

  • To assess occurrence of severe COVID-19 disease among individuals vaccinated with at least one dose of AZD1222 by age group, comorbidity group, severity of disease, number of vaccine dos

Neurodevelopment In HEU Children Exposed In Utero To Dolutegravir or Efavirenz and HIV-Unexposed Children (Motheo Study)

Study Objectives

  1. To assess developmental outcomes (neurodevelopment, psychosocial) at 2 years of age in HEU children exposed in utero to DTG/TDF/XTC (N=200); EFV/TDF/XTC (N=200); and community controls without HIV or ARV exposure (N=160), and compare outcomes between groups.
  2. To assess and compare developmental outcomes in the same children at 5 years of age.

Open-label access to dolutegravir for HIV-1 infected children and adolescents completing IMPAACT Studies P1093 and P2019: GSK205858

Primary Objectives: To provide access to age appropriate formulations of dolutegravir (DTG), either as Tivicay or as fixed dose combination (FDC) abacavir/dolutegravir/lamivudine (ABC/DTG/3TC), in an open-label protocol to eligible subjects who have completed the P1093 or IMPAACT 2019 parent studies.

Secondary Objectives: To assess any serious adverse events (SAEs) and any clinical or laboratory adverse events that lead to the discontinuation of lP (Tivicay or ABC/DTG/3TC/FDC).

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