Status:
UNKNOWN
Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF)
Lead Sponsor:
Cristina Mussini
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Long-term side effects of antiretrovirals (ART) have led to the introduction in clinical practice of NRTI-sparing regimens as double- or mono- therapy and their use is now recommended in specific popu...
Eligibility Criteria
Inclusion
- Age = 18 years
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Patients infected by HIV-1
- Patients under the first-line cART regimen with three antiretrovirals
- HIV-RNA \<=50 copies/mL for at least 12 months
- No previous virological failures/blips
- A female subject is eligible to enter the study if it is confirmed that she is:
- Not pregnant or nursing
- Of non-childbearing potential (e.g., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women \>54 years of age with cessation for =12 months of previously occurring menses)
- Of chilbearing potential and agrees to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs
- Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
- Male subjects must agree to utilize a highly effective method of contraception (as defined in Appendix 5) during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
- Male subjects must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.
Exclusion
- Patients with chronic hepatitis B
- Pregnant or breastfeeding women
- Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
- Known hypersensitivity to B/F/TAF FDC tablets, DTG and 3TC, their metabolites, or formulation excipient
- Subjects receiving ongoing therapy with any of the following medications in the table below, including drugs not to be used with B, F, TAF, DTG and 3TC.
- Administration of any of the previous medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study
- Documented resistance to any of the study drugs
- Active, serious infection (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1.
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with protocol requirements. -
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04054089
Start Date
September 1 2019
End Date
March 1 2021
Last Update
August 13 2019
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