Top

GILEAD

Projects

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children.

Rationale

The success of HAART and the apparent benefits of maximally suppressed viremia have shifted clinical attention towards ARV agents that optimize long-term safety and tolerability. Young, newly infected patients are diagnosed earlier, initiate therapy earlier, and look ahead towards lifelong therapy, often greater than 50 years {Prejean 2011}. Although more than 20 different ARV agents in 5 classes are available for the treatment of HIV infection in adults, adolescents and children have limited treatment options. Adolescents with HIV infection are in need of ARV regimens for which therapeutic dosing has been validated by PK data. Many adolescents with HIV infection would benefit from the availability of a simplified, once daily STR that combines potent efficacy, tolerability, a favorable toxicity profile, and practical, convenient dosing.

Investigators

  • Dr Muneerah Khan (Principal-Investigator)
  • Prof Lee Fairlie (Sub- Investigator)
  • Dr Faeezah Patel (Sub-Investigator)
  • Dr Elizea Horne (Sub-Investigator)
  • Dr Mrinmayee Dhar (Sub-Investigator)
  • Tiffany Seef (Clinical Associate)
  • Othusitse Segalo (Clinical Associate)

Latest Update

March 2024

For more details about Study please email rhicomms@wrhi.ac.za

Stay up to date

Get updates on news, resources, events and happenings from Wits RHI.