A Phase 4 interventional study of Symtuza® (TAF/FTC/DRV/c) and ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c) in HIV Infections, sponsored by Fundacion SEIMC-GESIDA. Completed at 6 sites in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Fundacion SEIMC-GESIDA · Phase 4, Interventional, and Treatment
A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c)
The investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 78 is close to the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Fundacion SEIMC-GESIDA is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who postpone switching from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) four weeks
Drug: ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Patients who switch from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) during the baseline visit
Drug: Symtuza® (TAF/FTC/DRV/c)
Treatment with TAF/FTC/DRV/c during 8 weeks since randomized
Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks
Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the Pittsburgh sleep quality index (PSQI). The PSQI contains 19 questions in total. These questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates medium difficulty, within their respective area. The score of the seven areas is finally added for a global score, which ranges from 0 to 21 points. "0" indicates ease of sleep and "21" severe difficulty in all areas
Time frame: week 4
Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale. Researchers will specifically ask the patient about eleven adverse effects at each visit. Each adverse effect will be documented and graduated, according to the criteria established in the "AIDS Clinical Trials Group (ACTG) Division of AIDS scale (2014)". Each adverse effect will be assigned a score between 0 and 3 points. The Score will include the individual scores for each of the eleven adverse effects collected, as well as the sum of all the individual scores presented by each patient at each study visit
Time frame: week 4
Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale. The scale includes 14 questions to evaluate the presence of depressive symptoms during the last week. Each question contains four answers with score between 0 and 3 points. To obtain the results of the questionnaire, the researcher must add the score obtained in the 7 questions of anxiety on the one hand and the 7 questions of depression on the other
Time frame: week 4
Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale
Time frame: Week 4 and 8 after switching to TAF/FTC/DRV/c
Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the Pittsburg sleep quality index (PSQI)
Time frame: Week 4 and 8 after switching to TAF/FTC/DRV/c
Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale.
Time frame: Week 4 and 8 after switching to TAF/FTC/DRV/c
Percentage of virologic failure after switching antiretroviral therapy from ABC/3TC/DTG to TAF/FTC/DRV/c
Virologic failure is defined as the presence of two consecutive HIV viral loads ≥ 50 copies/mL.
Time frame: Week 8 after switching to TAF/FTC/DRV/c
Plan to share: No
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Fundacion SEIMC-GESIDA