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HIVPhase 4NCT02351908

Renal Integrase Study

A Phase 4 study testing Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat), Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet and Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir) in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.

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 purpose of this study is to observe the safety of Truvada® (TDF/FTC) in relation to its impact on kidney function combined with different Integrase Inhibitors (Dolutegravir, or Elvitegravir/Cobicistat or Raltegravir), when given to patients who are commencing treatment for HIV infection for the first time. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
HIV
What is being tested?
Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat), Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet and Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2015to Apr 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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Is male or female aged 18 years or above
  • Has documented HIV-1 infection
  • Has signed the Informed Consent Form voluntarily
  • Is willing to comply with the protocol requirements, including dosing schedules of each regimen
  • Has a HIV-plasma viral load at screening >1000 copies/mL
  • Has any CD4 cell count
Show all 12Show fewer
  • Has never been exposed to ART (other than via PEP or PREP, not associated with acquisition of HIV)
  • Has an estimated glomerular filtration rate (MDRD method) >60 ml/min
  • Has no known resistance to TDF and FTC or to Integrase Inhibitors. HIV resistance test has to be dated no more than 1 year prior screening date. Only a RT/Pr gene resistance test is re-quired.
  • If female and of childbearing potential, she is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs); Dosing of the OCP may need to be adjusted if randomized to the Stribild® arm.
  • Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
  • If a heterosexually active male, he is using effective birth control methods and is willing to con-tinue practising these birth control methods during the trial and until follow-up visit

Who cannot join

  • Is infected with HIV-2
  • Is using any concomitant therapy disallowed as per SPC for the study drugs
  • Has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection-1993) with the following exceptions (must be discussed with the sponsor prior to enrolment):
  • Stable cutaneous Kaposi's Sarcoma (no pulmonary or gastrointestinal involvement other than oral lesions) unlikely to require systemic therapy during the trial period
  • CD4 count less than 200 cells/mm3 Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed
  • Has diabetes or any known or established renal disease or abnormality regardless of if stable
Show all 19Show fewer
  • Has presence at screening of proteinurea and or a urinary protein/creatinine ratio >30
  • Has untreated / not well controlled hypertension
  • Has acute viral hepatitis including, but not limited to, A, B, or C
  • Has chronic hepatitis B or chronic hepatitis C with AST and/or ALT >5 x ULN Note: Subjects co-infected with chronic HCV (but not B) can enter the trial if clinically stable and not expected to require treatment during the trial period.
  • Has received any investigational drug within 30 days prior to the trial drug administration
  • No baseline resistance test to reverse transcriptase inhibitors available
  • Clinically significant allergy or hypersensitivity or other contraindication to any trial medication or excipients
  • If female, she is pregnant or breastfeeding
  • Screening blood results with any grade 3 / 4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
  • Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L
  • Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
  • Is not using high protein training supplements such as creatinine or intermittently following exclusionary or high protein diets
  • Is not receiving medication with known relevant drug interactions or contraindications to any of the trial medications

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • SSAT Clinical Research Facility

    London, SW10 9NH

Other trials in United Kingdom

About this study

Official title: A Phase IV, Open-label Three-arm Study Investigating the Impact of a Combination of Tenofovir Disoproxil Fumarate/Emtricitabine With Raltegravir or Dolutegravir or Elvitegravir/Cobicistat on Renal Tubular Function and Renal Transporters in HIV-1 Antiretroviral naïve Patients

The purpose of this study is to observe the safety of Truvada® (TDF/FTC) in relation to its impact on kidney function combined with different Integrase Inhibitors (Dolutegravir, or Elvitegravir/Cobicistat or Raltegravir), when given to patients who are commencing treatment for HIV infection for the first time.

All three combinations (Raltegravir + Truvada®, Dolutegravir + Truvada® and Stribild®, a single pill which contains Elvitegravir/Cobicistat/Truvada®) are currently recommended by the national guide-lines and used in standard clinical practice.

Read the detailed description

The study will monitor kidney function, and compare the safety and effectiveness of Truvada® when taken with Dolutegravir, or Elvitegravir/Cobicistat or Raltegravir, over the first 48 weeks of treatment in HIV-1 antiretrovirals naïve patients.

The safety and how well these drug combinations are tolerated will be determined based on physical examinations, laboratory tests, and questions about any problems the participant might experience during the study. As part of this trial, levels of HIV-1 in the blood and urinary markers of kidney function and inflammatory markers will be measured at various times during the study.

The total duration of participant involvement in the trial will be up to 48 weeks, with up to 45 days between the screening and baseline visits. Participants will need to visit the clinic 6 times within the 48 weeks.

Once participants have been confirmed to be eligible to participate in the study, participants will attend for a baseline visit (day 1) where they will be randomly assigned to receive one of the three treatments listed below:

  • Treatment Arm 1: Stribild® (EVG/COBI/FTC/TDF) 1 tablet once a day
  • Treatment Arm 2: Isentress® (Raltegravir 400 mg) 1 tablet twice a day + Truvada® 1 tablet once a day
  • Treatment Arm 3: Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® 1 tablet once a day
Conditions
HIV
Being tested
Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat), Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet, Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)

What participants receive

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

  • Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat)Drug

  • Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tabletDrug

  • Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)Drug

Study groups in NCT02351908
Study groupRoleWhat they receive
Arm 1ExperimentalStribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat150mg/150mg/200mg/245mg) tablet 1 once daily for 48 weeks
Receives: Drug: Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat)
Arm 2ExperimentalIsentress® (Raltegravir 400 mg) 1 tablet twice a day + Truvada® (FTC \& Tenofovir) 1 tablet once a day for 48 weeks
Receives: Drug: Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet
Arm 3ExperimentalTivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC \& Tenofovir) 1 tablet once a day for 48 weeks
Receives: Drug: Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)

What is being measured

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

  1. Change in retinol-binding protein/creatinine ratio (PCR) with each regimen over 24 weeks.

    The change in retinol-binding protein/creatinine ratio (PCR) with each regimen over 24 weeks (measured via nephelometric assay run on Siemens BNII nephelometer).

    Measured: 24 weeks

Secondary outcomes (8)

  1. Change in retinol-binding protein/creatinine ratio with each regimen over 12 and 48 weeks.

    The change in retinol-binding protein/creatinine ratio (PCR) with each regimen over 12 and 48 weeks (measured via nephelometric assay run on Siemens BNII nephelometer)

    Measured: 48 weeks

  2. eGFR

    The variation from baseline of eGFR (C-G, MDRD with creatinine, CKD-EPI with creatinine / cystatin-C), creatinine, β2- and alpha1- microglobulin excretion, urinary albumin and pro-tein/creatinine ratio, urinary cystatin-C / creatinine ratio, fractional phosphate excretion (fasted plasma PO4 and urinary spot phosphate), plasma urate and rates of normoglycemic glycosuria on each regimen at week 4, 12, 24, 36, and 48 of therapy.

    Measured: 48 weeks

  3. Virologic response

    The proportion of patients achieving virologic response (HIV RNA < 40 cp/mL) on each regimen at week 4, 12, 24, 36 and 48.

    Measured: 48 weeks

  4. Immunologic markers

    The changes in immunologic markers (CD4+, CD8+, ratio) at weeks 4, 12, 24, 36 and 48 of therapy with each regimen.

    Measured: 48 weeks

  5. Inflammatory markers

    The changes in inflammatory markers (hsCRP, IL-6, d-dimer) at weeks 4, 12, 24 and 48 of therapy with each regimen.

    Measured: 48 weeks

  6. Metabolic markers

    The changes, from baseline in metabolic markers: lipids (TC, LDL, HDL, TGs), at 4, 12, 24, 36 and 48 weeks of therapy, and in insulin, fasting glucose and HOMA-i at 24 weeks of therapy with each regimen.

    Measured: 48 weeks

  7. Tenofovir concentration

    To measure tenofovir concentration (Ctrough 12 or 24) in plasma and urine, at week 4 of treat-ment with each regimen.

    Measured: 4 weeks

  8. Genetic polymorphisms

    Relationship between genetic polymorphisms and exposure to the studied drugs.

    Measured: 48 weeks

Timeline

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

  1. First posted30 Jan 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionApr 2016
  4. Study completionApr 2017

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02351908
Sponsor's protocol ID
SSAT 066
Status last verified
Apr 2017
First submitted
21 Jan 2015
Last updated
27 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat), Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet and Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir) in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.

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 12 inclusion and 19 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 27 Jun 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 United Kingdom. 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?

Change in retinol-binding protein/creatinine ratio (PCR) with each regimen over 24 weeks. (time frame: 24 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 NCT02351908.

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 27 Jun 2017.

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Renal Integrase Study (NCT02351908) | AzTrials