Treatment of HIV infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Genvoya
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: elvitegravir
CAS Number: 697761-98-1
Current Sponsor code: -
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age>18 years • Diagnosis of HIV-1 infection during PHI as determined by at least one of the following criteria: a) positive HIV viral load (2000 copies/mL) and negative HIV Ab/Ag Combo or Western Blot test, b) positive HIV Ab/Ag Combo test and negative or undetermined Western Blot test; c) positive HIV Ab/Ag Combo test and incomplete Western Blot test (no p31 protein reactivity); d) recent infection confirmed by a positive HIV-1 EIA or Western Blot test and a documented negative HIV-1 EIA within the previous 6 months • Being on first-line treatment of primary HIV-1 infection with either DRV/RTV or DRV/C +TDF/FTC + RAL treatment; minimum time on treatment is the time elapsed between start of ARV and first available HIV RNA 54years of age with cessation for >12 months of previously occurring menses) - Of childbearing potential (as defined in Appendix **) and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice sexual abstinence (as defined in Appendix **) 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. • Written Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Exclusion criteria • Presence of an opportunistic infection or an AIDS-defining illness, unless they are directly attributable to the acute seroconversion illness • Receipt of investigational research agents within 30 days prior to study entry • Receipt of prior experimental HIV vaccines. Individuals who received a saline placebo in a prior HIV vaccine trial are not excluded, provided that they did not receive a sham vector or an adjuvant. • Receipt of immunosuppressive medications or immune-modulators (e.g., cytokine therapy) within the past 6 months. • Current anti-tuberculosis prophylaxis or therapy • Serious illness other than acute HIV infection requiring systemic treatment or hospitalization until either therapy is completed or patient is clinically stable on therapy • Hepatitis C (HCV Ab positive) or hepatitis B infection (Positive hepatitis B surface antigen, HBsAg) • Women who are pregnant or breastfeeding • Renal function with CrCl below 50 mL/min • Severe hepatic impairment • Known hypersensitivity to the study drug, the metabolites or formulation excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ¿To evaluate efficacy of an early proactive switch to 1 single-pill E/C/F/TAF (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) from 4-pill treatment with either DRV (800 mg QD)+ RTV (100 mg QD) or DRV/C (800/150 mg QD) + RAL (400 mg BID) + TDF/FTC (300/200 mg QD) in patients with primary HIV-1 infection;Secondary Objective: ¿To evaluate immune recovery and immune activation in peripheral blood compartment ¿To evaluate safety ¿To evaluate adherence levels to ARVs by patient self-report ¿To evaluate levels of proviral HIV DNA ¿To evaluate HIV-1 RNA and HIV-1 DNA decay rates ¿To evaluate BMD change by DXA scan and on bone turn-over markers (BTM) ¿To evaluate renal function (e-GFR and eGFRcys), urinary tubular damage markers (a1-microglobulin, ¿2-microglobulin, RBP) and albumin-creatinine ratio (ACR) ¿To evaluate patient-reported quality of life ¿To evaluate neurocognitive performance ¿To evaluate resistance mutation development in subjects with virological failure ;Primary end point(s): •Percentage of subjects with Ultrasensitive HIV RNA <5 copies/mL at week 48 (FDA Snapshot algorithm);Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Percentage of subjects with HIV RNA <50 copies/mL at week 48 (FDA Snapshot algorithm); Percentage of subjects with Ultrasensitive HIV RNA <5 copies/mL at week 24 (FDA Snapshot algorithm); ¿ Discontinuation of any drug in the treatment combination ¿ WHO grade 3-4 toxicity at any laboratory exam ¿ Change in CD4+ T-cells in the peripheral blood (absolute and %) ; ¿ Total proviral HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) at baseline and at 6 and 12 months ¿ HIV antibody levels and Ab avidity test at baseline and 6 months ¿ Lymphocyte activation markers in PBMCs at baseline and at 6 and 12 months ¿ Inflammation markers (soluble CD14, IL-6, D-Dimer, vCam, C Reactive Protein) at baseline and 6 and 12 months ¿ Urinary tubular damage markers (¿1-microglobulin, ¿2-microglobulin, RBP) and albumin-creatinine ratio (ACR) at baseline and 6 and 12 months ¿ BMD change by DXA scan at baseline and at 12 months ¿ Bone turn-over markers (BMT) (CTX, P1NP) at baseline and at 6 and 12 months ; INSTI-mutations in genotypic resistance testing (GRT) at baseline and at virologic failure; Percentage of subjects discontinuing study drug ;Timepoint(s) of evaluation of this end point: 48 weeks; 24 weeks; nd; 6 and 12 months; baseline and virologic failure; nd | — |
Countries
Italy
Contacts
Public ContactImmunodeficenze virali
Istituto Nazionale per le Malattie Infettive ''Lazzaro Spallanzani''
Outcome results
None listed