Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial

Exclusion Criteria

• •If the patient has two VLs 2-3 months apart: \>2 log drop in VLs between the most recent VL (within the previous two months) and the immediately prior VL (taken 2-3 months prior)
• •CD4 count \<100 cells/microlitre
• •Estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
• •Alanine aminotransferase \>100 U/L or total bilirubin \>twice the upper limit of normal
• •Pregnant or desire to become pregnant during the study period (48 weeks)
• •Breastfeeding
• •Being treated for active tuberculosis (TB) or concern that patient has undiagnosed active TB (based on symptom screening) as rifampicin reduces the concentrations of dolutegravir and thus requires dose adjustments
• •Any current diagnosis of malignancy
• •Allergy or intolerance to one of the drugs in regimen
• •Active, severe psychiatric disease judged likely to impact adherence
• •Current substance abuse judged likely to impact adherence
• •On treatment for AIDS-defining condition (not including secondary prophylaxis maintenance therapy)
• •Any other clinical condition that in the opinion of an investigator puts the patient at increased risk if participating in the study