The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
167
150/150/200/10 mg FDC tablet administered orally once daily
300 mg tablet administered orally once daily
200 mg capsule administered orally once daily
200/300 mg tablet administered orally once daily
Tablet administered orally
Third agent may include one of the following regimens: lopinavir+ritonavir (LPV/r; Kaletra®), atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®), ATV + cobicistat (COBI;Tybost®) (or ATV/COBI FDC), DRV + RTV, darunavir (DRV; Prezista®) + COBI (or DRV/COBI FDC), fosamprenavir (FPV; Lexiva®) + RTV , saquinavir (SQV; Invirase®; Fortovase®) + RTV, efavirenz (EFV;Sustiva®), rilpivirine (RPV;Edurant®), nevirapine (NVP;Viramune®), etravirine (ETR;Intelence®), raltegravir (RAL; Isentress®), elvitegravir (EVG) + COBI, or dolutegravir (DTG;Tivicay®) Drug classes: * Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV, and SQV * Pharmacokinetic enhancer: COBI * Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR * Integrase inhibitors: RAL and DTG
CHU Saint-Pierre University Hospital
Brussels, Belgium
University Hospital Gent
Ghent, Belgium
CHU - Groupe Saint-Andre
Bordeaux, France
CHU de Dijon
Dijon, France
Hopital Europeen Marseille
Marseille, France
C.H.U. de Nantes
Nantes, France
Percent Change From Baseline to Week 48 in Spine BMD
Time frame: Baseline; Week 48
Percent Change From Baseline to Week 48 in Hip BMD
Time frame: Baseline; Week 48
Percent Change From Baseline to Week 24 in Spine BMD
Time frame: Baseline; Week 24
Percent Change From Baseline to Week 24 in Hip BMD
Time frame: Baseline; Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline; Week 24
Change in Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
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C.H.U. de NICE
Nice, France
CHU Hotel Dieu
Paris, France
Hopital Necker les Enfants Malades
Paris, France
Hopital Saint Antoine
Paris, France
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