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

• Status: Recruiting
• Trial end date: 2022-09-15
• Target enrollment: 0
• Participant gender: All

Summary

242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Treatments: Anti-Retroviral Agents

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

• Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC

• Any chronic autoimmune or inflammatory disease

• Use of immunomodulatory or immunosuppressive agents, including steroids Chronic treatment with aspirin, statins and other anti-inflammatory agents

• Any acute infection in the last 2 months

• 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

• Contraindication for the use of TAF

• 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

• 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.

• Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations