Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Fundacion SEIMC-GESIDA
- Enrollment
- 286
- Locations
- 36
- Primary Endpoint
- To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
Study Overview
Brief Summary
A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.
Detailed Description
Clinical Trial, phase IV, randomized, open label, multicenter with approved drugs in their use conditions.
A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signature of informed consent
- •At least 18 years old
- •Patients on their 1st ARV treatment consisting on 2 NRTIs + 1 third agent for at least 1 year
- •Undetectable viral load for at least 6 months prior to inclusion in the study (VL<50 c/mL in 2 determinations 6 months apart; blips are not allowed).
- •Requirement of ARV treatment change due to toxicity, intolerance or simplification.
- •Clinically stable.
Exclusion Criteria
- •Pregnant women or women who plan to get pregnant during the study.
- •Breast feeding
- •History of change of any ARV treatment component for any reason 4 months prior to the inclusion in the trial
- •History of ARV treatment change due to virological failure
- •History of confirmed virological failure defined as one single VL >400 c/mL or at least 2 VL between 50 and 400 c/mL one year after an indetectable VL was achieved.
- •Absence of HIV genotype prior to ARV treatment initiation.
- •Resistance mutation to any of the study drugs (ATV, RTV, 3TC)
- •HBV infection.
- •History of toxicity or intolerance to ATV, RTV or 3TC.
- •Gilbert's syndrome.
- •Use of contraindicated drugs.
- •Lab abnormalities grade 4.
Arms & Interventions
ATV/r+3TC
Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.
Intervention: Ritonavir boosted Atazanavir + Lamivudine (Drug)
ATV/r+2 NRTIs
Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.
Intervention: Ritonavir boosted Atazanavir + 2 NRTIs (Drug)
Outcomes
Primary Outcomes
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
Time Frame: Week 48
Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 48 weeks of treatment
Secondary Outcomes
- To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs(week 96)
- To assess safety after 24 weeks fo treatment(Week 24)
- To assess safety after 48 weeks fo treatment(Week 48)
- To assess safety after 96 weeks fo treatment(Week 96)
- To assess the incidence of resistance, and characterization of this resistance following a virological rebound(Week 96)
- To assess neurocognitive function evolution(Week 96)