Category
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Primary study
Registry of Trials»Pan African Clinical Trials Registry
Year
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2019
INTERVENTION: AZT 3TC plus Atazanavir and Ritonavir AZT 3TC plus LPV ritonavir TafED CONDITION: ; HIV/AIDS HIV/AIDS PRIMARY OUTCOME: 1. Virologic Endpoints; • HIV‐1 plasma RNA >1,000 copies/mL at week 144; 2. Toxicity Endpoints; • Grade 3 or 4 adverse event requiring discontinuation of therapy; SECONDARY OUTCOME: 1. Virologic Endpoints ; • HIV‐1 plasma RNA >1,000 copies/mL at weeks 24,48, 72, 96 and 144 ; • HIV‐1 plasma RNA >50 copies/mL at weeks 24,48, 72, 96 and 144 ; • Presence of genotypic resistance mutations at the time of Virologic failure and/or week 48 in patients with a viral load > 1,000 copies/mL ; 2. Toxicity Endpoints ; • Grade 2 adverse event requiring medical intervention and/or therapy ; 3. To compare immunologic response (CD4 T cell increase) at 24 and 48 weeks among clients switched from TDF/XTC/EFV or NVP to TDF or TAF/XTC/ DTG with undetectable viral load to those with detectable viral load at the time of switch ; 4. To compare immunologic response (CD4 T cell increase) at 72,96 and 48 weeks among clients switched from TDF/XTC/EFV or NVP to TDF or TAF/XTC/ DTG with undetectable viral load to those with detectable viral load at the time of switch ; 5. To identify baseline genotypic drug resistance profiles among patients having plasma viral load values > 1,000 copies/mL switched from TDF/XTC/EFV or NVP to TDF or TAF/XTC/ DTG ; 6. To compare genotypic drug resistance patterns among patients having plasma viral load values > 1,000 copies/mL at 24, 48, 72, 96 and 144 weeks among patients with detectable viral loads (i.e. > 50 copies/mL) versus undetectable (i.e. < 50 copies/mL) at the time of regimen switch. ; 7. To assess the patient characteristics (clinical, laboratory, and socio‐demographic) associated with detectable viremia at 24, 48, 72, 96 and 144 weeks among clients switched from TDF/XTC/EFV or NVP‐containing regimens to TDF or TAF/XTC/ DTG‐containing regimens. ; 8. To describe changes in longitudinal renal function (based on calculated creatinine clearance/estimated glomerular filtration rate (eGFR) using the CKD‐EPI equation) at 24, 48, 72, 96 and 144 weeks among clients switched from TDF/XTC/EFV or NVP‐containing regimens to TDF or TAF/XTC/ DTG‐containing regimens. ; 9. To compare changes in eGFR at 12, 24 and 48 weeks among patients switched to TDF/XTC/ DTG‐containing regimens as well as those switched to TAF/XTC/ DTG‐containing regimens; specifically looking at potential differences in renal function parameters (i.e. urine albumin‐to‐creatinine ratio (uACR), eGFR, serum creatinine changes, etc.) among patients receiving TDF‐ versus TAF‐based ART. ; 10. To compare virologic response (viral suppression rates) at 12,48,72, 96 and 144 weeks among clients switched from TDF/XTC/EFV or NVP to TDF or TAF/XTC/ DTG to those switched to AZT/3TC/LPV/r or ATV/r with viral load>1000 at the time of switch ; INCLUSION CRITERIA: Participants will eligible for study participation if they meet the following criteria: 1. HIV‐1 infection, as documented by confirmed licensed rapid test kit at any time prior to study entry 2. Taking TDF/XTC/EFV or NVP based ART 3. Male or female, age 18 or over 4. Ability and willingness to provide informed consent and willingness to comply with the requirements of the protocol, including being observed for 144 weeks on study, and complete all scheduled appointments and lab draws according to the national treatment guidelines and study protocol
Epistemonikos ID: 6c25da99bc93871cc2280edb4470f632143cb1e5
First added on: Aug 24, 2024