Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy (SALT)

Fundacion SEIMC-GESIDA

Status and phase: Completed; Phase 4

Conditions: HIV Infection

Treatments: Drug: Ritonavir boosted Atazanavir + 2 NRTIs; Drug: Ritonavir boosted Atazanavir + Lamivudine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01307488

2011-001107-12 (EudraCT Number)

GESIDA 7011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

ATV/r+3TC

Experimental group

Description:

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.

Treatment:

Drug: Ritonavir boosted Atazanavir + Lamivudine

ATV/r+2 NRTIs

Active Comparator group

Description:

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.

Treatment:

Drug: Ritonavir boosted Atazanavir + 2 NRTIs