A Phase 4 interventional study of BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo and Dovato 50Mg-300Mg Tablet + Biktarvy placebo in HIV Infections, sponsored by Fundacion SEIMC-GESIDA. Completed at 14 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Fundacion SEIMC-GESIDA · Phase 4, Interventional, and Treatment
In people infected with HIV, with suppressed HIV viral load and receiving treatment with DTG/3TC:
The change to BIC/FTC/TAF will decrease the development of adverse events of neuropsychiatric etiology.
The change to BIC/FTC/TAF may improve the patient´s tolerability and degree of acceptance and use of TAR.
The clinical trial is designed to compare people with HIV and neuropsychiatric vulnerabilities, the safety and tolerability of switch to BIC/FTC/TAF versus continue on DTG/3TC.
The study includes the inclusion of 80 participants with HIV and who present among their personal history any of those established among the selection criteria (insomnia, anxiety or depression), agree to participate in the same The participants, after signing the informed consent and verifying the meeting of the selection criteria, they will be randomized to continue for 48 weeks with DTG/3TC + BIC/FTC/TAF placebo (arm 1) or switch to BIC/FTC/TAF + placebo DTG/3TC (arm 2).
All participants, except those who discontinue the study early, must to complete the same schedule of visits. It will be cause of early discontinuation loss to follow-up, withdrawal of consent, or development of any condition that requires discontinuation or change of assigned treatment.
During follow-up, the management of the basic neuropsychiatric pathology of each participant will be performed in accordance with normal clinical practice. In no case, the beginning, the change or the cessation of any pharmacological treatment or neuropsychiatric intervention should be affected by their participation in the study. If the situation arises where any participant developed a severe neuropsychiatric adverse effect (grade 3-4), two specialists in psychiatry experts in the management of patients with HIV would be responsible for evaluating them through the review of their medical history and an interview with the participant in person or via telematics. This evaluation will aim to confirm the relevance of the continuity of the patient in the study and the need for further preferential evaluation by psychiatry.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 84 is close to the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Fundacion SEIMC-GESIDA is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DTG 50 mg/3TC 300 mg 1 tablet per day + BIC 50 mg/ FTC 200 mg/ TAF 25 mg placebo 1 tablet per day
Drug: Dovato 50Mg-300Mg Tablet + Biktarvy placebo
BIC 50 mg/ FTC 200 mg/ TAF 25 mg per day + DTG 50 mg/3TC 300 mg placebo1 tablet per day
Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo
The patients randomized to experimental arm will be randomized to Biktarvy + Dovato placebo
The patients randomized to comparador arm will be randomized to Dovato + Biktarvy placebo
The safety of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Primary endpoint: Proportion of neuropsychiatric adverse effects grade 2-4 (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11) Secondary endpoints: 1. Proportion of grade 2-4 adverse effects (defined using the AIDS Clinical Trials Group Adverse Events Grading Score11) 2. Proportion of ART discontinuations due to neuropsychiatric adverse effects. 3. Proportion of ART discontinuations for any reason.
Time frame: 24-48 weeks
The desirability of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Primary endpoint: Changes in sleep quality estimated using the Pittsburgh Sleep Quality Questionnaire (PSQI) Secondary endpoints: 1. Changes in mood estimated using the hospital scale of anxiety and depression (HADS) 2. Changes in the scale of satisfaction with ART (ESTAR) 3. Changes in the Spanish version of the MOS HIV quality of life questionnaire.
Time frame: 24-48 weeks
The efficacy of switching to BIC/FTC/TAF versus continuing treatment with DTG/3TC.
Primary endpoint: Percentage of participants with HIV viral load \>50 copies/mL, according to the Snapshot algorithm of the "US Food and Drug Administration" (margin to demonstrate non-inferiority: 4%) Secondary edpoints: * 1)Proportion of participants with HIV viral load \<50 copies/mL 2\) Proportion of participants with undetectable viral load. 3\) Proportion of patients with failure confirmed virology 4\) Percentage of patients with virological failure 5\) Proportion of participants experiencing blips during the study
Time frame: 24-48 weeks
Exploratory outcome: Brain integrity and functionality before and after switching to BIC/FTC/TAF.
Primary endpoint: Changes in brain volumes Secondary endpoints: 1. Changes in the levels of N-acetyl-aspartate, choline and myo-inositol at the frontal grey matter, frontal white matter, and basal ganglia 2. Changes in the integrity of the white matter 3. Changes in cerebral perfusion 4. Changes in brain resting state
Time frame: 48 weeks
Ran from Oct 2022 to primary completion in Feb 2024, 16 months.
Of 78 non-industry phase 4 interventional studies under HIV Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 45. This study's 16 months is below that.
Counting every sponsor, half of 90 studies reached it within 35 months; a quarter within 23 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Fundacion SEIMC-GESIDA