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HIV InfectionsPhase 4GENISNCT03693508

A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression

A Phase 4 study testing Genvoya® in people with HIV Infections and Severe Immunosuppression, run by Fundacion SEIMC-GESIDA at 6 sites in Spain.

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

Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
HIV Infections, Severe Immunosuppression
What is being tested?
Genvoya®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesSpain
Study dates
13 Apr 2018to 28 May 2020
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients able to give their written consent to participate in the study after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment
  • Adult patients (age ≥18 years) of both sexes
  • Patients with HIV-1 infection with severe immunosuppression, defined by a concentration of CD4 + lymphocytes <200 cells / μL
  • Patients who are allowed to perform a genotypic resistance test to inhibitors of intregrase, emtricitabine or tenofovir
  • Creatinine clearance ≥ 30 ml / min before the start of treatment
  • Alanine transaminase (ALT) / Aspartate transaminase (AST) levels not higher than five times normal levels, total bilirubin with normal values, neutrophils> 1000 cells / μL,> 50000 platelets / μL,> Hb level of 85 g / L and serum amylase levels <1 , 5 times higher normal limit before the start of treatment

Who cannot join

  • Patient who undergoes a concomitant treatment not allowed. Patient with documented intolerance or hypersensitivity to the study medication, or who is contraindicated to use it, attending a technical file
  • Patient receiving therapies with interferon, interleukin 2, cytotoxic chemotherapy or immunosuppressants at the baseline visit.
  • Patients with neoplasms, an exception of skin cancer and anus cancer in situ (stage 0)
  • Patient with any medical or psychological, sociological or geographical alteration, toxic habit (drugs, alcohol) that, a criterion of the researcher, may interfere in the fulfillment of the study by the patient. These conditions will be discussed with the patient before their inclusion in the trial
  • Patients with any medical or psychological alteration that, a criterion of the investigator, an involuntary factor of the patient's ability to understand and complement the questionnaires and scales used in the study
  • Patient in a treatment with any type of drug / product under investigation or who is participating in a clinical trial that uses a product under investigation, with the exception of studies in which the study treatment was completed more than 12 weeks ago
  • Pregnant women, in breastfeeding period or with a positive pregnancy test in the selection period; women of childbearing age and sexually active who are not willing to use an adequate contraceptive method during the study and up to 3 months after the administration of the last dose of study treatment. Some women in adulthood have undergone permanent infertility procedures or amenorrheic procedures for less than 12 months
  • Patients with severe hepatic impairment (Child-Pugh Class C).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • H. Ramón y Cajal

    Madrid, 28034

  • H. Clínico San Carlos

    Madrid, 28040

  • H. Doce de Octubre

    Madrid, 28041

  • Hospital Infanta Leonor

    Madrid

  • Hospital Costa del Sol

    Marbella, Malaga

  • Hospital virgen del Rocío

    Seville, 41013

Other trials in Spain

About this study

Official title: Phase IV, Open, Multicentre, Single-arm Study to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression.

Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment.

Read the detailed description

The patients included in the study will be treated during 48 weeks and will have to perform the selection/basal visit, week 4 visit, week 8 visit, week 12 visit, week 24 visit, week 48 visit and follow up visit.

Being tested
Genvoya®
Medical subject headings
HIV Infections

What participants receive

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

  • Genvoya®Drug

    Also called TAF/FTC/EVG-cb

    Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.

Study groups in NCT03693508
Study groupRoleWhat they receive
Arm 1ExperimentalNaive HIV patients with severe immunosuppression.
Receives: Drug: Genvoya®

What is being measured

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

  1. Percentage of patients with undetectable plasma viral load

    study the effectiveness of the combination of TAF/FTC/EVG-cb

    Measured: Week 48

Secondary outcomes (11)

  1. Proportion of patients with virological failure

    Proportion of patients with Plasma viral load of HIV-1 RNA ≥50 copies / mL in the last measurement while the patient receives the treatment in the window period, patients who interrupt the treatment prematurely due to lack / loss of efficacy in which the last viral load was ≥50 copies / mL or in which the antiretroviral treatment was modified before 48 weeks.

    Measured: From basal until week 48

  2. Proportion of patients with virological failure

    Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy

    Measured: From basal visit until week 48

  3. Proportion of patients with virological failure

    Proportion of patients who interrupt the treatment prematurely by others reasons (other than an adverse event, death or loss of effectiveness) and whose last viral load at the time of abandonment was ≥50 copies / mL.

    Measured: From basal visit until week 48

  4. Time to virological suppression

    viral load <50 copies / mL

    Measured: From basal until week 48

  5. Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed .

    virological failure defined by protocol as viral load> 1000 copies / mL at week 24 or 2 consecutive viral loads> 50 copies / mL (at least 2 weeks apart)

    Measured: From basal until week 48

  6. Time to virological failure

    Viral load ≥50 copias/mL

    Measured: From basal until week 48

  7. Incidence of genotypic resistance in patients with virological failure

    Measured: From basal until week 48

  8. Changes in viral load

    plasma concentration of HIV RNA

    Measured: Weeks 4, 8, 12, 24, 36 and 48

  9. Change in the CD4+ lymphocyte count

    Measured: Week 48

  10. Proportion of patients who have a CD4+ lymphocyte count > 200 cells / μL

    Measured: Week 48

  11. Mean time to reach a CD4 + lymphocyte count> 200 cells / μL

    Measured: From basal until week 48

Timeline

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

  1. First posted3 Oct 2018
  2. Study start13 Apr 2018
  3. Primary completion28 May 2020
  4. Study completion28 May 2020

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm, phase 4 study. The naive patients will be treated with elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693508
Sponsor's protocol ID
GESIDA 9216
Acronym
GENIS
Status last verified
Feb 2020
First submitted
1 Oct 2018
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Genvoya® in people with HIV Infections and Severe Immunosuppression, run by Fundacion SEIMC-GESIDA at 6 sites in Spain.

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 6 inclusion and 8 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 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. 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?

Percentage of patients with undetectable plasma viral load (time frame: Week 48). 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 NCT03693508.

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 7 Aug 2020.

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