Dolutegravir/Lamivudine as a single pill
Drug- Dose: Dolutegravir 50mg/ Lamivudine 300 mg -Route of adminstration: oral -Schedule of administration: once a day for 96 weeks.
NCT Number: NCT04884139
The hypothesize that DTG/3TC will be non-inferior to BIC/FTC/TAF with a 4% margin in virologically suppressed HIV-infected patients. The study will allow claiming for Superiority. Assuming that both DTG and BIC may lead to similar weight gains (approximately 1 kg after 48 weeks) in virologically suppressed HIV-infected patients and that TAF may induce a further weight gain (approximately 1 kg after 48 weeks), also hypothesize that switching to BIC/FTC/TAF may lead to greater weight gain than switching to DTG/3TC over 48 weeks.
This trial is a Phase IV, open-label, randomized multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virological suppression in HIV patients.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
H. Marina Baixa, Villajoyosa, Alicante, Spain
Participants will be randomly assigned in a 1:1 ratio to receive DTG/3TC or BIC/FTC/TAF. Randomization will be stratified by sex and TAF use at baseline. At least 33% of the patients included will be women.
The investigator will also endeavour to recruit as many non-Caucasian participants as possible.
Patients with TAF-containing regimens at baseline will be limited to 25% or less of the total number of participants.
Three sub-studies will be performed: Omics sub-study ; Senescence sub-study; Fat biopsies sub-study.
Omics sub-study: Assess the mechanistic pathways involved on weight changes associated with switching to BIC/FTC/TAF vs. DTG/3TC.
Senescence sub-study: Assess the potential effects on the telomere length, epigenetic age and oxidative stress markers of switching to BIC/FTC/TAF vs. DTG/3TC.
Fat biopsies sub-study: To assess potential effects of switching to BIC/FTC/TAF vs.
DTG/3TC on expression of marker genes of mitochondrial function, adipogenesis, and inflammation in subcutaneous fat tissue. Assays on adipose tissue gene expression will be complemented by analysis in serum of adipokines representative of adipose tissue function (leptin, adiponectin), and inflammation biomarkers (TNFalpha, MCP-1, IL-6, IL-8, IL-10, IL-18).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Week 48
Time frame: week 96
Time frame: Week 48 and week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Time frame: Basal, week 48 y week 96
Systolic and Diastolic Blood Pressure
Time frame: From basal, until week 96 , in each visit
Pittsburg Sleep Quality Index
Time frame: From basal, until week 96 , in each visit
Anxiety and depression (HAD) questionnaire
Time frame: From basal, until week 96 , in each visit
Quality of life (HIV-SI/SDM) questionnaire
Time frame: From basal, until week 96 , in each visit
Time frame: From basal, until week 96 , in each visit
Time frame: Week 48 and week 96
Fundacion SEIMC-GESIDA
Other
DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: an Open-label Randomized Clinical Trial
Acronym: PASO-DOBLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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