WMGS data from two-year, two-arm, randomized clinical trial comparing first-line antiretroviral therapy including dolutegravir vs. ritonavir-boosted darunavir in subjects with very advanced HIV-1 late presentation.
This was a substudy of the ADVANZ-4 trial (EudraCT: 2014-002281-70, ClinicalTrials.gov: NCT02337322), an open-label 2-arm randomized clinical trial where ART-naïve subjects with CD4+<100 cells/ml at diagnosis were randomised 1:1 to initiate dolutegravir (50 mg QD) or ritonavir-boosted darunavir (800/100 mg QD) in addition to co-formulated lamivudine (300 mg QD) / abacavir (150 mg QD). All subjects received cotrimoxazole prophylaxis until their CD4+ counts improved >200 cells/mm3. Study participants were followed prospectively for 96 weeks. Faecal samples were collected on day 1 of study medication intake (baseline) and on weeks 24, 48 and 96. For this microbiome analysis we used a modified intention to treat (mITT2) approach where only study participants who provided faecal samples at baseline or in at least two timepoints during the study follow-up were analysed.
This was a substudy of the ADVANZ-4 trial (EudraCT: 2014-002281-70, ClinicalTrials.gov: NCT02337322), an open-label 2-arm randomized clinical trial where ART-naïve subjects with CD4+<100 cells/ml at diagnosis were randomised 1:1 to initiate dolutegravir (50 mg QD) or ritonavir-boosted darunavir (800/100 mg QD) in addition to co-formulated lamivudine (300 mg QD) / abacavir (150 mg QD). All subjects received cotrimoxazole prophylaxis until their CD4+ counts improved >200 cells/mm3. Study participants were followed prospectively for 96 weeks. Faecal samples were collected on day 1 of study medication intake (baseline) and on weeks 24, 48 and 96. For this microbiome analysis we used a modified intention to treat (mITT2) approach where only study participants who provided faecal samples at baseline or in at least two timepoints during the study follow-up were analysed.
IrsiCaixa Institute for AIDS Research, Badalona, Spain