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Phase IV, a Clinical Trial to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities

NCT05549180 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-07-18

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo

The patients randomized to experimental arm will be randomized to Biktarvy + Dovato placebo

DRUG

Dovato 50Mg-300Mg Tablet + Biktarvy placebo

The patients randomized to comparador arm will be randomized to Dovato + Biktarvy placebo

Sponsors & Collaborators

  • Fundacion SEIMC-GESIDA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2024-02-13
Completion
2024-08-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549180 on ClinicalTrials.gov