A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection

Korábbi kezelés

• Any suspicion or confirmation of resistance to TAF, 3TC, FTC, DTG or BIC. In case of have a study of baseline resistance mutations prior to the start of ART has to rule out resistance to investigational drugs.
• Use of immunomodulatory or immunosuppressive agents, including steroids Chronic treatment with aspirin, statins and other anti-inflammatory agents
• Estimated glomerular filtration rate (TFGe) <30 mg / ml / m2 measured by any of the formulas available. The determination of the TFGe of a previous routine analysis of ≤ 12 weeks prior to signing the consent is allowed
• Simultaneous participation in another clinical trial or research study that requires the need of treatment with other drugs outside the study or interfere with the visits of the same.

Más betegség

• Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC
• Any chronic autoimmune or inflammatory disease
• Any acute infection in the last 2 months
• Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will finish the study

Egyéb

• Inability to obtain written informed consent to participate in the study
• Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods.
• Contraindication for the use of TAF
• Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations

• Men and women ≥ 18 years
• Confirmed and documented diagnosis of HIV-1 infection
• Virological suppression of more than 48 weeks (confirmed with HIV RNA <50 copies / ml). The determination of the CV of a routine prior analysis of ≤ 12 weeks prior to signature of consent.
• ART in stable dual therapy (> 48 weeks) with DTG + 3TC
• Signed informed consent
• Negative pregnancy test in urine or blood