Status:
COMPLETED
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
Lead Sponsor:
Fundacion SEIMC-GESIDA
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2024
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04076423
Start Date
October 10 2019
End Date
January 16 2024
Last Update
October 1 2024
Active Locations (18)
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1
Hospital San Pedro
Logroño, La Rioja, Spain, 26006
2
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain, 28002
3
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
4
Hospital de Bellvitge
Barcelona, Spain