Phase
Condition
N/ATreatment
Lopinavir Boosted with ritonavir (LPV/r)
F/TAF (Lowest Dose TOS)
Cobicistat (High Dose)
Clinical Study ID
Ages > 1 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474,GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to studyparticipation.
Exclusion
Key Exclusion Criteria:
Individuals planning to switch to B/F/TAF on Day 1 cannot have plasma HIV RNA ≥ 50copies/mL during the last parent study visit prior to screening/Day 1 visit.
Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay beingused if the limit of detection is ≥ 50 copies/mL).
Individuals planning to switch to B/F/TAF must not have any ongoing Grade 3 or 4drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratoryabnormality (confirmed on repeat) related to any component of B/F/TAF prior totreatment switch.
For those on B/F/TAF or planning to switch to B/F/TAF: previous treatmentdiscontinuation of any component of B/F/TAF due to toxicity or intolerance.
For those planning to switch to B/F/TAF: known hypersensitivity to any component ofthe study drug, its metabolites, or formulation excipients.
Ongoing treatment with or prior use of any prohibited medications.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Helios Salud
Buenos Aires, C1141 ACG
ArgentinaActive - Recruiting
Hospital del Niño
Panama City, 0816-00383
PanamaActive - Recruiting
University of Stellenbosch
Cape Town, 7505
South AfricaActive - Recruiting
Enhancing Care Foundation
Durban, 3629
South AfricaActive - Recruiting
Rahima Moosa Mother and Child Hospital
Johannesburg, 2112
South AfricaActive - Recruiting
Be Part Yoluntu Centre
Paarl, 7626
South AfricaActive - Recruiting
The Aurun Institute
Pretoria, 0087
South AfricaActive - Recruiting
Perinatal HIV Research Unit
Soweto, 2013
South AfricaActive - Recruiting
Faculty of Medicine - Mahidol University
Bangkok Noi, 10700
ThailandActive - Recruiting
Khon Kaen University
Khon Kaen, 40002
ThailandActive - Recruiting
Joint Clinical Research Centre
Kampala, 10005
UgandaActive - Recruiting
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