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Trial record 22 of 79 for:    Elvitegravir OR Elvitegravir[TREATMENT] AND HIV [CONDITION]

Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

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ClinicalTrials.gov Identifier: NCT02616029
Recruitment Status : Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

This two part study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in HIV-1 reverse transcriptase.

In Part 1, participants will have M184V and/or M184I (mixtures are acceptable) in reverse transcriptase without any other NRTI resistance mutation. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2. In Part 2, participants will have M184V and/or M184I (mixtures are acceptable) in reverse transcriptase with or without 1 or 2 thymidine analog-associated mutations.


Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: E/C/F/TAF Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
Actual Study Start Date : December 17, 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: E/C/F/TAF
Participants will switch from their current regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF FDC and will receive treatment for 48 weeks.
Drug: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily
Other Name: Genvoya®




Primary Outcome Measures :
  1. Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 12 as defined by pure virologic response (PVR) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Proportion of participants with emergence of new mutations in HIV-1 reverse transcriptase and integrase [ Time Frame: Up to 48 weeks ]
    This outcome measure will be assessed with any post Day 1 sample with HIV-1 RNA ≥ 50 copies/mL.

  2. Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 using PVR [ Time Frame: Weeks 24 and 48 ]
  3. Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12, 24 and 48 using the FDA snapshot analysis [ Time Frame: Weeks 12, 24, and 48 ]
  4. Proportion of participants with CD4+ cell count change from Day 1 at Weeks 12, 24 and 48 [ Time Frame: Day 1, Weeks 12, 24, and 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Documented historical genotype report showing M184V and/or M184I (mixtures are acceptable) in reverse transcriptase. Individuals must not have any primary integrase strand transfer inhibitor (INSTI) or primary protease inhibitor (PI) resistance mutations present on historical genotype; non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations are allowed.
  • Proviral DNA test must not have additional exclusion resistance mutations against PIs, NRTIs and INSTIs

    • Part 1 (first 50 individuals): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITHOUT any other NRTI resistance mutation (including thymidine analogue-associated mutations (TAMs) [TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R], K65R, T69 insertion and Q151M mutation complex [A62V, V75I, F77L, F116Y, Q151M]
    • Part 2 (after the interim efficacy review - 50 individuals): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITH or WITHOUT one or two thymidine analogue-associated mutations (TAMs) [TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R]. Evidence of K65R, K70E, T69 insertion and/or Q151M mutation complex [A62V, V75I, F77L, F116Y, Q151M] will not be eligible
  • Currently receiving an antiretroviral regimen consisting of FTC/TDF or ABC/3TC in combination with one third antiretroviral agent for ≥ 6 consecutive months preceding the screening visit
  • Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening visit
  • Estimated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • A female individual is eligible to enter the study if it is confirmed that she is:

    • not pregnant
    • of non-childbearing potential
    • stopped menstruating for ≥ 12 months
    • of childbearing potential and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs
  • Male individuals must agree to use the protocol specified method(s) of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from screening throughout the study period and for 30 days following the last study drug dose

    • Male individuals must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose

Key Exclusion Criteria:

  • 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). Individuals may have evidence of prior virologic failure on only an NNRTI plus 2 NRTI-based regimen
  • Individuals on a current PI/r-based regimen will have no evidence of previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time)
  • Hepatitis C infection that would require therapy during the study
  • Hepatitis B surface antigen (HBsAg) positive
  • Individuals with clinical evidence of decompensated cirrhosis (e.g., ascites, encephalopathy, variceal bleeding, etc.)
  • Have an implanted defibrillator or pacemaker
  • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and must not be anticipated to require systemic therapy during the study
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616029


Locations
United States, California
Southern California Men's Medical Group
Los Angeles, California, United States, 90069
United States, Florida
Midway Immunology & Research Center, LLC
Fort Pierce, Florida, United States, 34982
Orlando Immunology Center
Orlando, Florida, United States, 32803
Triple O Research Institute PA
West Palm Beach, Florida, United States, 33401
France
Hopital Sainte Marguerite - Hospital
Marseille, France, 13009
CHU de Nantes
Nantes, France, 44093
CHU de Nice-l Archet
Nice, France
CHR Orleans la Source
Orleans, France
Hopital Saint Louis
Paris Cedex 10, France
CHU Hotel Dieu
Paris Cedex 14, France
Hopital Necker les Enfants Malades
Paris Cedex 15, France
CHU Tours Service de Médecine Internes et Maladies Infectieuses
Tours, France
Germany
Universitatsklinikum Essen
Essen, Germany
Infektiologikum Frankfurt
Frankfurt, Germany, 60596
ICH Study Center- Dedicated Research
Hamburg, Germany, 22083
Universitat Mainz
Mainz, Germany
Italy
IRCCS A.O.U. San Martino
Genova, Italy
Dipartimento di Malattie Infettive e Tropicali dell'Università di Milano
Milano, Italy
Fondazione IRCCS San Raffaele del Monte Tabor
Milano, Italy
Dipartimento di Malattie Infettive e Tropicali
Torino, Italy
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clinic de Barcelona - Hospital
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre - Hospital
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02616029     History of Changes
Other Study ID Numbers: GS-US-292-1824
2015-002710-74 ( EudraCT Number )
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors