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PRJEB76817 ERP161310

Gut microbiome in late-presenting HIV, DTG vs DRV/r trial, Spain

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.

271 faecal samples from adults with advanced HIV-1 infection in Spain, collected during a randomized trial comparing dolutegravir vs. ritonavir-boosted darunavir as first-line antiretroviral therapy. machine-written summary

271 samples · 271 runs · ES · Adult · 2024 · 6.72 Gbp / sample

Sources
✓Sequence archive 1,355✓Abstract / description 16○Full text✓Supplementary tables 2,348–External resources–User contribution–Human verified

Checked this project's papers and archive records yourself? Mark it human-verified.

what each source gave
✓ Sequence archive1,355 sample values (collection date, country, latitude, location region, longitude)
✓ Abstract / description16 sample values (health condition, health condition detail)
○ Full textread; no usable statement or table · PMC12960958
✓ Supplementary tables2,348 sample values (age, bmi, health condition, health condition detail, intervention, medication, sex, subject id)
– External resourcesnot covered by the external resources we ingest
– User contributionnothing uploaded yet
– Human verifiednot yet checked by a person · I checked this project — verify it
Interventions

intervention — arms not resolved

Non-antibiotic pharmaceutical given as the study intervention (metformin design randomized_controlled_trial · population other_infection · Lamivudine/abacavir plus dolutegravir vs ritonavir-boosted darunavir (ART)

“randomized (1:1) to initiate lamivudine/abacavir plus either dolutegravir or ritonavir-boosted darunavir” — abstract:41781390 (study level; per-sample arms are in the intervention column below)

Samples at a glance
1 sampling locations · 1 country
Age
adult261
elderly10
Condition
other_infection271
Sex
male229
female34
Country
ES271
Body site
primary271
Sequencing depth per sample · this project all projects
all projects, 0–0.03 Gbp: 25,080 samples (4 %)all projects, 0.03–0.1 Gbp: 17,066 samples (3 %)all projects, 0.1–0.3 Gbp: 29,179 samples (5 %)all projects, 0.3–1 Gbp: 47,044 samples (8 %)all projects, 1–3 Gbp: 124,983 samples (22 %)this project, 1–3 Gbp: 3 samplesall projects, 3–10 Gbp: 253,728 samples (44 %)this project, 3–10 Gbp: 265 samplesall projects, 10–30 Gbp: 72,533 samples (13 %)this project, 10–30 Gbp: 3 samplesall projects, 30–100 Gbp: 3,024 samples (1 %)all projects, 100–300 Gbp: 106 samples (0 %)all projects, ≥ 300 Gbp: 9 samples (0 %)project median 6.72 Gbp per sample0130Gbp
Sampling design and relatedness

longitudinal

79 of 88 people sampled more than once (254 samples; median 3, up to 4 per person) · follow-up median 22 mo (max 22 mo) · median interval between samples 11 mo (time from visit codes mapped to the stated schedule). Schedule stated by the source: “Faecal samples at day 1 (baseline) and weeks 24, 48 and 96”; stated follow-up 22 mo.

A001A001: day 0A001: day 168A001: day 336A001: day 672A002A002: day 0A002: day 168A002: day 336A002: day 672A006A006: day 0A006: day 168A006: day 336A007A007: day 0A007: day 168A007: day 504A008A008: day 0A008: day 168A008: day 336A008: day 672A009A009: day 0A009: day 168A009: day 336A009: day 672A011A011: day 0A011: day 168A011: day 336A011: day 672A012A012: day 0A012: day 168A012: day 336A012: day 672A013A013: day 0A013: day 168A013: day 336A013: day 672A020A020: day 0A020: day 168A020: day 336A020: day 672A021A021: day 0A021: day 168A021: day 336A021: day 672A022A022: day 0A022: day 168A022: day 336A022: day 672A023A023: day 0A023: day 168A023: day 336A023: day 672A024A024: day 0A024: day 168A024: day 336A024: day 672A028A028: day 0A028: day 168A028: day 336A028: day 672A029A029: day 0A029: day 168A029: day 336A029: day 672A031A031: day 0A031: day 168A031: day 336A031: day 672A033A033: day 0A033: day 168A033: day 336A033: day 672A034A034: day 0A034: day 168A034: day 336A034: day 672A036A036: day 0A036: day 168A036: day 336A036: day 672A037A037: day 0A037: day 168A037: day 336A037: day 672B005B005: day 0B005: day 168B005: day 336B005: day 672B007B007: day 0B007: day 168B007: day 336B007: day 672D005D005: day 0D005: day 168D005: day 336D005: day 672D007D007: day 0D007: day 168D007: day 336D007: day 672D009D009: day 0D009: day 168D009: day 336D009: day 672D010D010: day 0D010: day 168D010: day 336D010: day 672D011D011: day 0D011: day 168D011: day 336D011: day 672D012D012: day 0D012: day 168D012: day 336D012: day 672D013D013: day 0D013: day 168D013: day 336D013: day 672D014D014: day 0D014: day 168D014: day 336D014: day 672D015D015: day 0D015: day 168D015: day 336D015: day 672E013E013: day 0E013: day 168E013: day 336E013: day 672E015E015: day 0E015: day 168E015: day 336E015: day 672E016E016: day 0E016: day 168E016: day 336E016: day 672E017E017: day 0E017: day 168E017: day 336E017: day 6720 d6 mo11 mo17 mo22 mo

Each row is one person (36 shown of 79); dots are samples at days since that person's first sample.

How longitudinal and relatedness information is derived

Community composition
Prevotella 13.6%Faecalibacterium 6.0%Blautia_A 4.8%Roseburia 3.6%Collinsella 3.5%Bifidobacterium 3.2%Bacteroides 2.2%Mediterraneibacter 1.9%Gemmiger 1.8%Vescimonas 1.8%Ruminococcoides 1.7%Phocaeicola 1.5%not assigned to a genus 5.3%other genera 49.1%

Genera, mean relative abundance over 243 profiled gut samples of this project (Sandpiper SingleM profiles, GTDB R232; low-depth and non-metagenome profiles left out).

Field coverage
fieldsamplescoverageR1R2R3R4
age_category271 100%
country271 100%271
health_condition271 100%2638
subject_id263 97%263
collection_date271 100%271
detailed_location271 100%
health_condition_detail271 100%2638
latitude271 100%271
location_region271 100%271
longitude271 100%271
age_at_collection_days263 97%263
intervention263 97%263
medication263 97%263
sex263 97%263
timepoint_label263 97%263
bmi244 90%244
Papers (1)
  • Dolutegravir restores gut microbiota in late-stage HIV-1 unlike darunavir: an open-label, randomized clinical trial. 2026 PMID 41781390 PMC12960958 own_data
Details
Archive description

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.

How this project entered the registry

Classified as human gut / stool shotgun DNA metagenome of adult by sonnet_x2 with confidence 0.75. Assay shotgun_dna.

  • host study.description · “ART-naïve subjects with CD4+<100 cells/ml”
  • body site run.scientific_name · “feces metagenome”
  • body site study.description · “Faecal samples were collected on day 1”
  • life stage study.description · “CD4+<100 cells/ml at diagnosis”
Evidence examples (one per field × route)
samplefieldvaluerouteconf.sourcequote
SAMEA115761322age_at_collection_days10957.5R20.75paper.supp.sup_fig_4C_rmcorr.tsv[!age]age=30
SAMEA115761322bmi23.9R20.85paper.supp.sup_fig_1ABC_marker_abundance.tsv[!BMI]23.880301228695995
SAMEA115761322collection_date2017-01-01R10.90biosample.attribute:collection_date2017-01-01
SAMEA115761322countryESR10.90sample.attr.geographic_location_country_and_or_seaSpain
SAMEA115761322health_conditionother_infectionR20.85paper.supp.fig_3D_dissimilarity.tsv[!HIV_Status]ADZ4_100: HIV_Status=positive
SAMEA115761332health_conditionother_infectionR40.50paper.abstractadvanced HIV-1 infection
SAMEA115761322health_condition_detailHIV_Status: positiveR20.85paper.supp.fig_3D_dissimilarity.tsv[!HIV_Status]ADZ4_100: HIV_Status=positive
SAMEA115761332health_condition_detailadvanced HIV-1 infection with median CD4+ T cells of 34 cells/mm3R40.50paper.abstractadvanced HIV-1 infection
SAMEA115761322interventiondrug_therapyR20.85paper.supp.fig_3D_dissimilarity.tsv[!type]ADZ4_100: type=DTG
SAMEA115761322latitude40.4637R10.90biosample.attribute:geographic_location_latitude+geographic_location_longitude40.463667 -3.74922
SAMEA115761322location_regionMadridR10.60biosample.attribute:geographic_location_latitude+geographic_location_longitude40.463667 -3.74922
SAMEA115761322longitude-3.7492R10.90biosample.attribute:geographic_location_latitude+geographic_location_longitude40.463667 -3.74922
SAMEA115761322medicationantiretroviralR20.85paper.supp.sup_fig_1ABC_marker_abundance.tsv[!treatment]ADZ4_100: treatment=DTG
SAMEA115761322sexmaleR20.80paper.supp.fig_3G_rmcorr_treatment.tsv[!gender]gender=male
SAMEA115761322subject_idA020R20.85paper.supp.sup_fig_1ABC_marker_abundance.tsv[!record_id]A020
SAMEA115761322timepoint_label24R20.85paper.supp.sup_fig_1ABC_marker_abundance.tsv[!time_point]24
Sequencing

271 runs over 271 samples · mean 6.73 Gbp per run (median 6.72 Gbp, total 1,824.63 Gbp; 271 runs with a base count) · layout PAIRED 271 · platform ILLUMINA 271 · models Illumina HiSeq 2500 (271) · 90% of runs with a Sandpiper profile · first public 2024-10-10

Authors (17)

Català-Moll F first · Blázquez-Bondia C · Farré-Badia J · Torres F · Manzardo C · Bonfill E · Curran A · Domingo P · Podzamczer D · Force L · Falcó V · Parera M · Casadellà M · Miró JM · Noguera-Julian M · Paredes R · ADVANZ-4 MISTRAL investigators last

Downloads

PRJEB76817.csv.gz (10.0 KB) · parquet (82.7 KB) — all 271 samples, every field with route and confidence · PRJEB76817_determinations.csv.gz (31.1 KB) — 3,719 evidence rows

Samples (271 · every field this project has values for · hover a cell for its source)
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