NCT02499978

Brief Summary

This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 9, 2021

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

July 14, 2015

Last Update Submit

July 7, 2021

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • Virologic suppression (24 weeks)

    Compare between arms the proportion of patients maintaining virologic suppression (i.e., no confirmed HIV RNA levels ≥200 copies/mL) at Week 24

    24 weeks

Secondary Outcomes (1)

  • Virologic Suppression (48 weeks)

    48 weeks

Study Arms (2)

DRV/COBI, DTG Immediate switch

EXPERIMENTAL

DARUNAVIR/COBICISTAT (800mg/150MG), DOLUTEGRAVIR 50MG DAILY at randomization and follow through week 48.

Drug: Darunavir/CobicistatDrug: Dolutegravir

DRV/COBI, DTG Delayed Switch

ACTIVE COMPARATOR

DARUNAVIR/COBICISTAT (800MG150MG), DOLUTEGRAVIR 50MG DAILY at week 24 and follow through week 48.

Drug: Darunavir/CobicistatDrug: Dolutegravir

Interventions

Darunavir/CobicistatDRUG

Fixed dose combination medication

Also known as: Prezcobix, DRV/COBI
DRV/COBI, DTG Delayed SwitchDRV/COBI, DTG Immediate switch
DolutegravirDRUG

single tablet medication

Also known as: Tivicay, DTG
DRV/COBI, DTG Delayed SwitchDRV/COBI, DTG Immediate switch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. A second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test or a previous detectable HIV RNA level.
  • Age ≥ 18 years
  • \. HIV-1 RNA \<50 copies/mL while on a stable antiretroviral regimen for at least 6 months prior to study entry excluding blips (i.e., a single measurement \<200 copies/mL preceded and followed by measurements \<50 copies/mL)
  • \. At screening, patient on a stable antiretroviral regimen containing at least one NRTI and a PI, NNRTI, or INSTI
  • \. No changes in antiretroviral regimen in the six months prior to screening (except for a switch to a coformulated tablet from the component tablets)
  • \. A desire to switch off current antiretroviral therapy due to: a) Renal dysfunction (microalbuminuria/proteinuria or CrCl\<70 mL/min/1.73 m2) on tenofovir disoproxil fumarate (TDF) of tenofovir al; b) Osteopenia or osteoporosis on a TDF-containing regimen (i.e., lowest T-score ≥1.0 standard deviation below the young adult mean measured by dual-energy x-ray absorptiometry); c) Peripheral neuropathy or lipoatrophy at least partially attributable to ongoing NRTI use; d) Intermediate or high Framingham risk (i.e., ≥10% 10-year risk) on an abacavir-containing regimen; e) Patient preference.
  • \. Laboratory values within six months of screening visit
  • Hemoglobin ≥8.0 g/dL
  • Platelet count ≥40,000/mm3
  • AST, ALT, and alkaline phosphatase ≤5 × ULN
  • Total bilirubin ≤2.5 x ULN (except for those on atazanavir-containing regimens)
  • Calculated creatinine clearance (CrCl) ≥45 mL/min as estimated by the Cockcroft-Gault equation:
  • For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)\*
  • \*For women, multiply the result by 0.85 = CrCl (mL/min)
  • \. For women of reproductive potential, negative serum or urine pregnancy test at screening and a negative urine pregnancy test at the entry visit prior to randomization and also agreeable to using a contraceptive of choice during the study period.
  • +1 more criteria

You may not qualify if:

  • Current CD4+ T-cell count \<200 cells/µL
  • Current antiretroviral regimen consisting of three of more antiretroviral classes
  • History of genotypic resistance, phenotypic resistance or intolerance to either DRV or DTG.
  • Prohibited protease mutations: V11I, V32I, L33F, I47V/A/L, I50V, I54T/S/L/M, T74P, L76V, V82F, I84V, or L89V
  • Prohibited INSTI mutations: E92Q, E92K/A, G140S/A/C, Q148H/R/K or Q148 substitution plus any of the following: L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.
  • History of virologic failure while on an INSTI prior to study enrollment
  • Severe hepatic impairment (Child Pugh Class C)
  • Hepatitis B Surface Antigen Positive
  • Breastfeeding, pregnancy, or plans to become pregnant during the study
  • Known allergy/sensitivity to any study drug or their formulations.
  • Receipt or planned receipt of prohibited concomitant medications (See section 5.2.1)
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study procedures and treatment.
  • Serious medical illness that, in the opinion of the site investigator, precludes safe participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Univerity

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

cobicistat mixture with darunavirdolutegravir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Philip Grant, MD

    Stanford University

    STUDY DIRECTOR

  • Sean Collins, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 16, 2015

Study Start

May 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 9, 2021

Record last verified: 2016-10

Locations

US(2)