HIV INFECTION
Conditions
Interventions
Trade Name: EVIPLERA
Product Name: EVIPLERA
Pharmaceutical Form: Capsule, hard
Trade Name: ATRIPLA
Product Name: ATRIPLA
Pharmaceutical Form: Capsule, hard
Sponsors
AZIENDA OSPEDALIERA SAN GERARDO, MONZA, ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age greater than 18 years, and ability to provide informed consent - Treatment with TDF, FTC and EFV for at least 180 days at the time of screening co-formulated in Atripla® - HIV-1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - History of previous failure to antiretroviral therapy or of mutations associated with resistance to NRTIs or NNRTIs; - Treatment, in progress or planned, with proton pump inhibitors or with other contraindicated medications - Presence of any contraindication to the use of the study drugs; - Diagnosis of AIDS in the 30 days prior to screening; - Prior diagnosis of AIDS Dementia Complex; - Dependence on alcohol or other substances - Major psychiatric disorders - Plasma creatinine> 1.2 mg / dl or glomerular filtration rate 3 times the upper normal value - Decompensated cirrhosis - Any other medical condition or prior therapy that makes the subject unsuitable for the study or unable to follow the correct dosage or dietary prescriptions - Women of childbearing potential not using contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the switch from TDF / FTC / EFV to TDF / FTC / RPV is associated with an improvement in neurocognitive performance or neuropsychological wellness;Secondary Objective: - To evaluate if the switch to TDF / FTC / RPV is associated with a rate of HIV virologic suppression comparable to that obtained with regimen containing EFV. - To evaluate if the switch from TDF / FTC / EFV to TDF / FTC / RPV is associated with an improvement in fasting lipid parameters. - To evaluate if the switch from TDF / FTC / EFV to TDF / FTC / RPV is associated with an improvement in the quality of life perceived by patients. - To evaluate if the switch from TDF / FTC / EFV to TDF / FTC / RPV is associated with an improvement in subjective CNS disorders. - Measure the proportion of patients who, in the course of a stable regimen containing EFV, present: • mild EFV-associated CNS side effects, • mild or asymptomatic neurocognitive impairment;Primary end point(s): - Proportion of patients with an improvement in neurocognitive performance in one of the investigated domains, evaluated in binary form (Normal / Abnormal) or on a continuous scale (absolute change in deficit score) - Proportion of patients with an improvement in the scores of depression, anxiety or sleep quality, measured in binary (Yes / No) and on a continuous scale - Proportion of patients with an improvement in any of the two previous binary end-point (composite end point);Timepoint(s) of evaluation of this end point: 28 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Symptomatic, neuropsychological or neurcognitive end-points • Variation in scores of quality of life • Proportion of patients with an improvement in CNS symptoms • Proportion of patients with an improvement in the CFQ - Virological end-points • Proportion of patients with HIV-RNA 50 copies /ml results in two consecutive determinations, distant at least 4 weeks apart • Number of patients with genotypic resistance at failure - Immunological end-points • Modification from baseline of CD4+ and CD8+ T cells at weeks at 12 and 24 - Safety and tolerability end-points • Proportion of patients who discontinue treatment because of intolerance to study drugs or due to the development of adverse events • Proportion of patients who develop an adverse event of grade III or IV;Timepoint(s) of evaluation of this end point: 28 WEEKS | — |
Countries
Italy
Contacts
Public ContactUFFICIO RICERCA
AZIENDA OSPEDALIERA SAN GERARDO, MONZA, ITALIA
Outcome results
None listed