CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 167 enrolled
Drug / intervention
E/C/F/TAF +5 moredrug
Likely dose
E/C/F/TAF 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02616783
NCT02616783Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Open-Label Study to Evaluate 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 Subjects Aged ≥ 60 Years

Gilead Sciences·interventional·Posted Nov 30, 2015·Updated Mar 4, 2020

In Brief

A Phase 3 clinical trial evaluating E/C/F/TAF, TDF, and 4 other interventions for HIV-1 Infection. Completed, enrolled 167 participants across 35 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesBelgium, France, Italy, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 30, 2015
Enrollment StartDec 22, 2015
Primary CompletionFeb 21, 2018
Study CompletionMar 21, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.6 years ago

Interventions

E/C/F/TAFdrug

150/150/200/10 mg FDC tablet administered orally once daily

TDFdrug

300 mg tablet administered orally once daily

FTCdrug

200 mg capsule administered orally once daily

FTC/TDFdrug

200/300 mg tablet administered orally once daily

3TCdrug

Tablet administered orally

Third agentdrug

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