Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years

Summary

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.

Timeline

Start

2015-12-22

Primary completion

2018-02-21

Completion

2018-03-21

Outcome

Met primary endpoint

registry analysis (superiority test); E/C/F/TAF vs Stay on Baseline Regimen; p <0.001; Difference in Percentages 2.427 (95% CI 1.337 to 3.517); ANOVA NCT02616783 ↗

registry analysis (superiority test); E/C/F/TAF vs Stay on Baseline Regimen; p <0.001; Difference in percentages 2.036 (95% CI 1.168 to 2.904); ANOVA NCT02616783 ↗

Publications

• Maggiolo F, Rizzardini G, Raffi F, Pulido F, Mateo-Garcia MG, Molina JM, Ong E, Shao Y, Piontkowsky D, Das M, McNicholl I, Haubrich R. Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial. Lancet HIV. 2019 Oct;6(10):e655-e666. doi: 10.1016/S2352-3018(19)30195-X.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	E/C/F/TAF	Unknown	10 mg	Oral
Subject	E/C/F/TAF	Unknown	150 mg	Oral
Subject	E/C/F/TAF	Unknown	200 mg	Oral
Comparator	FTC/TDF	Unknown	200 mg	Oral
Comparator	FTC/TDF	Unknown	300 mg	Oral
Comparator	TDF	Unknown	300 mg	Oral
Comparator	Atazanavir	Other / unclassified	—	—
Comparator	Cobicistat	Small molecule	—	—
Comparator	Darunavir	Small molecule	—	—
Comparator	Dolutegravir	Other / unclassified	—	—
Comparator	Efavirenz	Other / unclassified	—	—
Comparator	Etravirine	Small molecule	—	—
Comparator	FTC	Unknown	200 mg	Oral
Comparator	Fosamprenavir	Small molecule	—	—
Comparator	Lamivudine	Other / unclassified	—	Oral
Comparator	Lopinavir	Other / unclassified	—	—
Comparator	Nevirapine	Small molecule	—	—
Comparator	Raltegravir	Other / unclassified	—	—
Comparator	Rilpivirine	Small molecule	—	—
Comparator	Ritonavir	Other / unclassified	—	—
Comparator	Saquinavir	Small molecule	—	—

Indications