HIV Infection
Conditions
Keywords
HIV, AIDS, Atazanavir, Simplification
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.
Interventions
DRUGRitonavir boosted Atazanavir + Lamivudine
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.
DRUGRitonavir boosted Atazanavir + 2 NRTIs
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.
Sponsors
Bristol-Myers Squibb
Fundacion SEIMC-GESIDA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs | 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
| Measure | Time frame | Description |
|---|---|---|
| To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs | week 24 | 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 24 weeks of treatment |
| To assess safety after 24 weeks fo treatment | Week 24 | Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening. |
| To assess neurocognitive function evolution | Week 48 | Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48 |
| To assess safety after 96 weeks fo treatment | Week 96 | Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening. |
| To assess the incidence of resistance, and characterization of this resistance following a virological rebound | Week 96 | Genotypic antiretroviral resistance profiles of subjects experiencing virologic failure (genotype) Plasma samples at Baseline and at each visit will be stored for additional resistance studies (i.e. cDNA) |
| To assess safety after 48 weeks fo treatment | Week 48 | Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening. |
Countries
Spain
Outcome results
None listed