Elvitegravir/Cobicistat/Tenofovir DF/Emtricitabine With Darunavir Treatment Simplification Strategy

NCT02199613 | Completed Phase 4

• 1 other identifier: H14-00490
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the safety and efficacy of darunavir 800mg plus the co-formulated elvitegravir/cobicistat/tenofovir disoproxil fumarate (DF)/emtricitabine (Stribild) tablet as a simplification strategy for the treatment of HIV infection in HIV-infected subjects who have had previous antiretroviral treatment experience with multiple-drug regimens. We hypothesize that elvitegravir/cobicistat/tenofovir DF/emtricitabine with darunavir will offer a safe and efficacious treatment simplification strategy for HIV positive patients currently receiving multiple-drug regimens to control their HIV infection.

Conditions

HIV Infection

Keywords

HIV; antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• Plasma HIV RNA

  Proportion of individuals with plasma HIV RNA \<200copies/mL at 12 weeks following regimen switch

  12 weeks

Secondary Outcomes (11)

• plasma HIV RNA

  weeks 12, 24 and 48

• plasma HIV RNA

  week 24 and 48

• CD4 cell count, CD4% and CD4/CD8 ratio

  12, 24 and 48 weeks

• serum creatinine and estimated glomerular filtration rate (eGFR)

  12, 24, and 48 weeks

• Adverse event discontinuations

  48 weeks

Study Arms (1)

Treatment simplification

EXPERIMENTAL

Open-label darunavir 800mg in conjunction with the co-formulated tenofovir DF/FTC/cobicistat/elvitegravir (Stribild) tablet, both taken together once daily with food

Drug: Treatment simplification

Interventions

Treatment simplification DRUG

Eligible, consenting subjects will start open-label darunavir 800mg plus the co-formulated tenofovir DF/FTC/cobicistat/elvitegravir (Stribild) tablet once daily with food, following the study procedures at the baseline visit. They will be assessed at weeks 2, 12, 24, 36, and 48 after starting the new regimen.

Also known as: Darunavir 800mg plus Stribild tablet once daily

Treatment simplification

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive adults \> or = 19 years of age
• receiving stable therapy including one or two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in conjunction with a once-daily protease inhibitor (PI) (atazanavir, lopinavir or darunavir) and twice daily raltegravir or once daily dolutegravir
• Virologic suppression for \>6 months, defined as plasma viral load (VL) consistently \< 200 copies/mL with no evidence of prior virologic rebound (VL \> 1000 copies/mL) on the NRTI/PI/Raltegravir regimen, AND VL \< 50 copies/mL at time of study screening
• Estimated glomerular filtration rate (eGFR) \> o r= 70mL/min at screening

You may not qualify if:

• Prior documented viral rebound \> 1000 copies/mL on any raltegravir-containing regimen
• Evidence of resistance mutations compromising raltegravir or elvitegravir activity on prior genotypes.
• Evidence of clinically significant resistance to tenofovir on any previous genotype tests: K65R mutation, or 3 or more thymidine-analogue associated mutations (TAMS) compromising tenofovir activity
• Evidence of resistance mutations significantly compromising darunavir activity on any previous genotypic tests
• Current use of any nonnucleoside reverse transcriptase inhibitor (NNRTI)
• Pregnancy or breast-feeding
• Contraindications to tenofovir/FTC, elvitegravir, or cobicistat (e.g. previous significant toxicity, intolerance or drug interactions

Sponsors & Collaborators

• University of British Columbia: lead
• Gilead Sciences: collaborator

Study Sites (1)

St. Paul's Hospital Immunodeficiency Clinic

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

• Harris M, Ganase B, Watson B, Harrigan PR, Montaner JSG, Hull MW. HIV treatment simplification to elvitegravir/cobicistat/emtricitabine/tenofovir disproxil fumarate (E/C/F/TDF) plus darunavir: a pharmacokinetic study. AIDS Res Ther. 2017 Nov 2;14(1):59. doi: 10.1186/s12981-017-0185-4.

  PMID: 29096670 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark Hull, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 24, 2014
• Study Start: October 1, 2014
• Primary Completion: February 14, 2017
• Study Completion: February 14, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CA (1)