155
Participants
Start Date
December 5, 2019
Primary Completion Date
January 15, 2024
Study Completion Date
January 15, 2024
Darunavir (DRV) 800 milligram (MG) Oral Tablet
800 milligrams (mg) orally once daily for 96 weeks
Ritonavir 100 MG Oral Tablet
100 mg orally once daily for 96 weeks
N(t)RTIs
Choice of N(t)RTIs determined by clinician guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection
Dolutegravir 50 MG Oral Tablet
50 mg orally once daily for 96 weeks
TDF 300 MG Oral Tablet
300 mg orally once daily for 96 weeks
3TC 300 MG Oral Tablet
300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician
FTC 200 MG Oral Cap
200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician
University of Zimbabwe Clinical Research Centre, Harare
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto
Desmond Tutu HIV Foundation, Cape Town
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre, Bangkok
Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site, Chennai
Univerity of Malaya Medical Centre, Kuala Lumpur
Clinical HIV Research Unit, Helen Joseph Hospital, Westdene
Lead Sponsor
Kirby Institute
OTHER_GOV