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 (InSTINCT)

Fundacion SEIMC-GESIDA

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Dual Therapy; Drug: Triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04076423

GeSIDA 10918

Details and patient eligibility

About

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)

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

141 participants in 2 patient groups

Experimental arm:

Experimental group

Description:

they will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization.

Treatment:

Drug: Triple therapy

Comparator arm

Active Comparator group

Description:

they will take 1 tablet of 50 mg of DTG orally, once a day + 1 tablet of 300 mg of 3TC orally, once a day, from the randomization moment.

Treatment:

Drug: Dual Therapy