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Clinical Trials

MainTitle

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 (pts > 60 yrs)

This study is ongoing, but not recruiting participants.
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02616783

First received: November 23, 2015
Last updated: October 4, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

This study will 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.

Condition Intervention Phase
HIV-1 Infection

Drug : E/C/F/TAF
Drug : TDF
Drug : FTC
Drug : FTC/TDF
Drug : 3TC
Drug : Third agent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Percent change from baseline to Week 48 in spine and hip bone mineral density (BMD) [ Time Frame: Baseline; Week 48 ]
Secondary Outcome Measures:
  • Percent change from baseline to Week 24 in spine and hip BMD [ Time Frame: Baseline; Week 24 ]
  • Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as defined by the Food and Drug Administration (FDA) snapshot algorithm [ Time Frame: Week 24 and 48 ]
  • Change in CD4+ cell count from baseline at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ]

Enrollment: 166
Study Start Date: December 22, 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: E/C/F/TAF
Participants will switch from tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or 3TC plus a third agent to E/C/F/TAF and will receive treatment for 48 weeks.
Drug: E/C/F/TAF

E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Other Name: Genvoya®
Active Comparator: Remain current regimen
Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
Drug: TDF

TDF 300 mg tablet administered orally once daily

Other Name: Viread®
Drug: FTC

FTC 200 mg capsule administered orally once daily

Other Name: Emtriva®
Drug: FTC/TDF

FTC/TDF 200/300 mg tablet administered orally once daily

Other Name: Truvada®
Drug: 3TC

3TC tablet administered orally

Other Name:
  • Lamivudine
  • Epivir®

Drug: Third agent
  • 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

Eligibility

Eligibility

Ages Eligible for Study: 60 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Key Inclusion Criteria:

  • Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs) regimen plus a third agent for ≥ 6 consecutive months prior to screening visit. For individuals with 3 or more ART regimens, a regimen history must be provided for approval by the Sponsor.

  • Refer to assigned interventions for allowed third agents of the current regimen.
  • Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay). In the preceding 6 months prior to screening, one episode of "blip" (HIV-1 RNA > 50 and < 400 copies/mL) is acceptable, only if HIV-1 RNA is < 50 copies/mL immediately before and after the "blip".
  • Plasma HIV-1 RNA level < 50 copies/mL at screening visit
  • Adequate renal function
  • Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula (eGFRCG) and are on ARVs that are appropriately dose adjusted for renal function per package insert
  • All documented historical plasma genotype(s) must not show resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutations K65R, K70E, M184V/I, or thymidine analog-associated mutations (TAMs) that include M41L, L210W, D67N, K70R, T215Y/F, K219Q/E/N/R. If historical plasma prior to first ART is not available or individual has 3 or more ART regimens, individuals will have proviral genotype analysis prior to Day 1 to confirm absence of archived resistance to TDF or FTC.
  • Study performed DXA scan and T-score received prior to Day 1

  • Key

Exclusion Criteria:
  • Previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) if the current regimen contains a PI/r
  • Individuals will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV)
  • A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4+ cell count and/or percentage criteria)
  • Hepatitis C virus that would require therapy during the study
  • Individuals receiving ongoing treatment for bone disease (eg, osteoporosis), including
bisphosphonates, denosumab, and strontium ranelate
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02616783

Locations

Belgium
CHU Saint-Pierre University Hospital
Brussels, Belgium
University Hospital Gent
Ghent, Belgium
France
CHU - Groupe Saint-Andre
Bordeaux, France
CHU de Dijon
Dijon, France
Hopital Europeen Marseille
Marseille, France
C.H.U. de Nantes
Nantes, France
C.H.U. de NICE
Nice, France
Hopital Saint Louis
Paris cedex 10, France
Hopital Saint Antoine
Paris cedex 12, France
CHU Hotel Dieu
Paris, France
Hopital Necker les Enfants Malades
Paris, France
Hopital Haut-Leveque
Pessac, Cedex, France
Service des Maladies Infectieuses et du Voyageur
Tourcoing, France
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Busto Arsizio Hospital
Busto Arsizio, Italy
IRCCS A.O.U. San Martino
Genova, Italy
Azienda Ospedaliera Luigi Sacco
Milano, Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Italy
U.O. Malattie Infettive
Pescara, Italy
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
Roma, Italy
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy
Dipartimento di Malattie Infettive e Tropicali
Torino, Italy
Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Ramon Y Cajal University Hospital
Madrid, Spain
Hospital Costa Del Sol
Marbella, Spain
Hospital General Universitario de Valencia
Valencia, Spain
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Mortimer Market Centre
London, United Kingdom
Newcastle Royal Victoria Infirmary
Newcastle Upon Tyne, United Kingdom

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02616783   History of Changes  
Other Study ID Numbers: GS-US-292-1826  
  2015-002712-32  
Study First Received: November 23, 2015  
Last Updated: October 4, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Gilead Sciences:

HIV 1 Infection
HIV
Virologically-Suppressed

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.