HIV InfectionPhase 4QuaDarNCT02199613

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

A Phase 4 study testing Treatment simplification in people with HIV Infection, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: HIV Infection
What is being tested?: Treatment simplification
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteCanada
Study dates: Oct 2014to 14 Feb 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

St. Paul's Hospital Immunodeficiency Clinic
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: Elvitegravir/Cobicistat/Tenofovir DF/Emtricitabine With Darunavir in Treatment-experienced Patients: Quality Control Monitoring of a Treatment Simplification Strategy

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.

Read the detailed description

Eligible, consenting subjects will be assessed at baseline and weeks 2, 12, 24, 36, and 48. Study medications will be dispensed at all visits except week 2, and all participants will commence taking open-label darunavir 800mg in conjunction with the co-formulated tenofovir DF/emtricitabine/cobicistat/elvitegravir (Stribild) tablet, both taken together once daily with food, following study procedures at baseline.

Assessments at the study visits will include:

Complete physical exam including height and weight at baseline; symptom-directed physical exam and weight at other visits
Adverse clinical events including serious adverse events (hospitalizations etc.) and medication changes at every visit.
HIV RNA every 4 weeks.
CD4 and CD8 absolute counts and % at all visits except week 2.
Platelet count, aspartate amino transferase (AST), creatinine, estimated glomerular filtration rate (eGFR), phosphorus, urinalysis, and urine albumin to creatinine ratio (UACR) at each visit.
Fasting lipids (total, HDL, and LDL cholesterol and triglycerides), apolipoprotein B, high-sensitivity C- reactive protein (hsCRP) at baseline, week 24, and week 48.
Pregnancy test for women of child-bearing potential (as defined above) at every visit except week 2. In addition, pregnancy tests will be performed monthly for women of child-bearing potential; between study visits these may be done at home.
A plasma sample (3 mL) will be collected and stored once at baseline for all subjects, and used for measurement of darunavir trough (pre-dose) concentration in subjects receiving darunavir in their pre-study regimen.
All subjects will take their study medication under observation in the clinic on Day 14, and plasma samples (3mL) for pharmacokinetic testing will be drawn immediately pre-dose and at 1, 2, 3, 4, 5, 6, and 8 hours post-dose. Subjects will return the following day before taking their Day 15 dose for a 24-hour post-dose sample.
Peripheral blood mononuclear cells (PBMCs) will be collected and stored at baseline for possible future study-related testing.
The following questionnaires will be completed by participants prior to other study procedures at baseline and at weeks 24 and 48: MOS-HIV quality of life questionnaire; HIVTSQ; ACTG treatment adherence questionnaire; and the medication adherence self-report inventory (MASRI).

Conditions: HIV Infection
Being tested: Treatment simplification
Keywords: HIV, antiretroviral therapy
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment simplificationDrug
Also called Darunavir 800mg plus Stribild tablet once daily
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.

Study groups in NCT02199613
Study group	Role	What they receive
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 Receives: Drug: Treatment simplification

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (11)

plasma HIV RNA
Proportion of individuals with plasma HIV RNA < 50 copies/mL at weeks 12, 24 and 48 post switch
Measured: weeks 12, 24 and 48
plasma HIV RNA
Proportion of individuals with plasma HIV RNA < 200 copies/mL at week 24 and 48 post switch
Measured: week 24 and 48
CD4 cell count, CD4% and CD4/CD8 ratio
Change in CD4 cell count, CD4% and CD4/CD8 ratio from study baseline to 12, 24 and 48 weeks after switch.
Measured: 12, 24 and 48 weeks
serum creatinine and estimated glomerular filtration rate (eGFR)
Change in serum creatinine and eGFR from baseline to 12, 24 weeks and 48 weeks.
Measured: 12, 24, and 48 weeks
Adverse event discontinuations
Proportion of adverse events experienced necessitating switch to original regimen
Measured: 48 weeks
fasting lipid parameters (total cholesterol, LDL, HDL, triglycerides, and apolipoprotein B [apoB]), AST to platelet ratio index (APRI) score, and high-sensitivity C-reactive protein (hsCRP)
Changes in fasting lipid parameters (total cholesterol, LDL, HDL, triglycerides, and apolipoprotein B [apoB]), AST to platelet ratio index (APRI) score, and high-sensitivity C-reactive protein (hsCRP) between baseline and 24 and 48 weeks.
Measured: 24 and 48 weeks
Darunavir plasma concentration
Change in darunavir trough concentration from baseline to week 2 for individuals receiving darunavir at baseline
Measured: week 2
HIV Treatment Satisfaction Questionnaire (HIVTSQ) scores and quality of life indicators (MOS-HIV scores)
Changes in HIV Treatment Satisfaction Questionnaire (HIVTSQ) scores and quality of life indicators (MOS-HIV scores) between baseline and weeks 24 and 48 following switch.
Measured: weeks 24 and 48
Adherence
Changes in antiretroviral adherence from baseline to 24 and 48 weeks. Adherence will be assessed using two measures: the ACTG treatment adherence questionnaire and the Medication adherence self-report inventory (MASRI).
Measured: 24 and 48 weeks
Elvitegravir plasma concentrations
Elvitegravir concentrations will be measured at day 14
Measured: Day 14
Adverse events
Adverse events necessitating a resumption of the previous antiretroviral regimen, and all serious adverse events will be recorded.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201414 Feb 2017

First posted24 Jul 2014 (estimated)
Study startOct 2014
Primary completion14 Feb 2017
Study completion14 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02199613
Sponsor's protocol ID: H14-00490
Other IDs: H14-00490
Acronym: QuaDar
Status last verified: Nov 2017
First submitted: 22 Jul 2014
Last updated: 6 Nov 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 29096670

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Elvitegravir/Cobicistat/Tenofovir DF/Emtricitabine With Darunavir in Treatment-experienced Patients: Quality Control Monitoring of a Treatment Simplification Strategy
ClinicalTrials.gov ID: NCT02199613
Acronym / sponsor ID: QuaDar / H14-00490
Conditions: HIV Infection
Keywords: HIV, antiretroviral therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: Oct 2014
Primary completion: 14 Feb 2017 (actual)
Study completion: 14 Feb 2017 (actual)
First posted: 24 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Assessments at the study visits will include:

Complete physical exam including height and weight at baseline; symptom-directed physical exam and weight at other visits
Adverse clinical events including serious adverse events (hospitalizations etc.) and medication changes at every visit.
HIV RNA every 4 weeks.
CD4 and CD8 absolute counts and % at all visits except week 2.
Platelet count, aspartate amino transferase (AST), creatinine, estimated glomerular filtration rate (eGFR), phosphorus, urinalysis, and urine albumin to creatinine ratio (UACR) at each visit.
Fasting lipids (total, HDL, and LDL cholesterol and triglycerides), apolipoprotein B, high-sensitivity C- reactive protein (hsCRP) at baseline, week 24, and week 48.
Pregnancy test for women of child-bearing potential (as defined above) at every visit except week 2. In addition, pregnancy tests will be performed monthly for women of child-bearing potential; between study visits these may be done at home.
A plasma sample (3 mL) will be collected and stored once at baseline for all subjects, and used for measurement of darunavir trough (pre-dose) concentration in subjects receiving darunavir in their pre-study regimen.
All subjects will take their study medication under observation in the clinic on Day 14, and plasma samples (3mL) for pharmacokinetic testing will be drawn immediately pre-dose and at 1, 2, 3, 4, 5, 6, and 8 hours post-dose. Subjects will return the following day before taking their Day 15 dose for a 24-hour post-dose sample.
Peripheral blood mononuclear cells (PBMCs) will be collected and stored at baseline for possible future study-related testing.
The following questionnaires will be completed by participants prior to other study procedures at baseline and at weeks 24 and 48: MOS-HIV quality of life questionnaire; HIVTSQ; ACTG treatment adherence questionnaire; and the medication adherence self-report inventory (MASRI).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment simplification	Experimental	Drug: Treatment simplificationOpen-label darunavir 800mg in conjunction with the co-formulated tenofovir DF/FTC/cobicistat/elvitegravir (Stribild) tablet, both taken together once daily with food

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment simplificationAlso: Darunavir 800mg plus Stribild tablet once dailyEligible, 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.	Drug	Treatment simplification

Primary outcome

Plasma HIV RNA
Time frame: 12 weeks
Proportion of individuals with plasma HIV RNA <200copies/mL at 12 weeks following regimen switch

11 secondary outcomes

plasma HIV RNA
Time frame: weeks 12, 24 and 48
plasma HIV RNA
Time frame: week 24 and 48
CD4 cell count, CD4% and CD4/CD8 ratio
Time frame: 12, 24 and 48 weeks
serum creatinine and estimated glomerular filtration rate (eGFR)
Time frame: 12, 24, and 48 weeks
Adverse event discontinuations
Time frame: 48 weeks
fasting lipid parameters (total cholesterol, LDL, HDL, triglycerides, and apolipoprotein B [apoB]), AST to platelet ratio index (APRI) score, and high-sensitivity C-reactive protein (hsCRP)
Time frame: 24 and 48 weeks
Darunavir plasma concentration
Time frame: week 2
HIV Treatment Satisfaction Questionnaire (HIVTSQ) scores and quality of life indicators (MOS-HIV scores)
Time frame: weeks 24 and 48
Adherence
Time frame: 24 and 48 weeks
Elvitegravir plasma concentrations
Time frame: Day 14
Adverse events
Time frame: 48 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Derived from this study: PubMed 29096670Harris 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.

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NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Hull, MD principal investigator

University of British Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Treatment simplification in people with HIV Infection, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma HIV RNA (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02199613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.