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HIV-InfectionPhase 3DualisNCT02486133

Dual Therapy With Boosted Darunavir + Dolutegravir

A Phase 3 study testing Prezista, Norvir and Tivicay in people with HIV-Infection, run by Technical University of Munich at 1 site in Germany.

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

A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV) Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) in HIV patients, who are on a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-Infection
What is being tested?
Prezista, Norvir and Tivicay
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
1 siteGermany
Study dates
Jul 2015to 31 May 2018
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • HIV infection with HIV RNA < 50 cps/ml within a period of at least 24 weeks suppressive ART prior to randomization, with one accepted blip of HIV RNA < 200 cps/ml and well-tolerated antiretroviral therapy: consisting of 2 NRTI (ABC/3TC, F/TDF or F/TAF) in combination with DRV/r for a period of at least 28 days prior to randomizsation.
  • No known genotypic DRV- or integrase inhibitor-related HIV resistance
  • Signed written informed consent
  • Documented negative HLA B*57:01 (only in case of Abacavir-containing ART)
  • A female subject may be eligible to enter and participate in the study if she:
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  • is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
  • is of child-bearing potential with a negative pregnancy test at both screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
  • Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IMP, throughout the study, and for at least 2 weeks after discontinuation of all study medications
  • Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
  • Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject
  • Approved hormonal contraception without DRV/r interactions and a barrier method
  • Any other method with published data showing that the expected failure rate is <1% per year. Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IMP.

Who cannot join

  • Pregnant women and nursing mothers
  • Chronic HBV infection (HBsAg positive); known anti-HBsAb > 10 IU/ml within the last 36 months or a history of infection with known anti-HBcAb positive AND anti-HBsAb > 10 IU/ml AND HBsAg-loss are not exclusionary)
  • Any evidence of a Center for Disease Control and Prevention (CDC) Category C disease at screening, except cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts < 200 cells/mm3 or historic CDC C diseases are not exclusionary
  • History or presence of allergy to the study drugs or their components
  • Subject has creatinine clearance of <50 mL/min by MDRD eGFR calculation
  • Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), OR ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)
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  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Subjects with severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
  • Anticipated need for interferon-based Hepatitis C virus (HCV) therapy during the study
  • Participation in other interventional clinical trials at the same time
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
  • Persons held in an institution by legal or official order
  • Imprisoned people, people requiring in-house treatment for psychiatric disorders or people who are unable to give informed consent

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum rechts der Isar

    Munich, 81675

Other trials in Germany

About this study

Official title: A Prosp., Multic., Randomized, Open-label Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Boosted Darunavir + Dolutegravir When Switching From SOC ART in HIV-patients With Sustained Virological Suppr.

A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV) Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with RTV-boosted DRV in combination with 2 NRTIs.

Read the detailed description

Modern combination antiretroviral therapy (cART) leads to well-controlled HIV infection with a potentially normal life expectancy. Nucleosidic reverse transcriptase inhibitors (NRTIs) play a major role as "ART backbone" and are essential antiretroviral agents according to current European and WHO HIV treatment guidelines. However, NRTI use can be associated with substantial side effects, e.g. bone and kidney toxicity, lipotoxicity and mitochondrial toxicity and can put patients at serious risk. Especially long-term NRTI-exposure is a risk factor for these often cumulative side effects, since the standard of care (SOC) therapy with the different NRTIs consists of the combination of multiple substances. Furthermore NRTI resistances may emerge over time and limit treatment options for pre-treated HIV patients.

As a consequence, alternative NRTI free (so called "nuke sparing") therapy options have been evaluated in different studies but were associated with less virologic therapeutic success and higher rates of therapy induced resistance compared to standard regimens in ART naïve patients. This is particularly true for patients with a high baseline viral load.

As an alternative to NRTI-based therapy options, Ritonavir-boosted protease inhibitor (PI/r)-based nuke-sparing dual therapies have been studied widely, mostly in combination with the integrase inhibitor (INI) Raltegravir (RAL). In this setting, the PI was not fully capable to prevent the development of INI resistant viruses.

The HIV protease inhibitor Darunavir (DRV) and the novel INI Dolutegravir (DTG) are both very potent anchor drugs with a high barrier to resistance. Due to a favourable side-effect profile, a once-daily (QD) formulation and its virological potency, DRV is currently one of the most frequently used PIs in Europe and the USA. In addition, the new, once-daily administrable integrase inhibitor DTG showed an excellent tolerability profile as well as a high resistance barrier.

The nuke-free combination of DTG (50 mg) with the Ritonavir (/r)- or Cobicistat-boosted protease inhibitor DRV (800 mg) may offer a favorable safety and efficacy profile with the advantage of QD-dosing.

Conditions
HIV-Infection
Being tested
Prezista, Norvir, Tivicay, Truvada, Kivexa
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

  • PrezistaDrug

    Also called Darunavir

    once daily

  • NorvirDrug

    Also called Ritonavir

    once daily

  • TivicayDrug

    Also called Dolutegravir

    once daily

  • TruvadaDrug

    Also called Tenofovir disaproxil fumarat/emtricitabine

    once daily

  • KivexaDrug

    Also called Abacavir/Lamivudine

    once daily

  • DescovyDrug

    Also called Tenofovir alafenamid / emtricitabine

    once daily

Study groups in NCT02486133
Study groupRoleWhat they receive
A: boosted darunavir (bDRV) plus dolutegravir (DTG; 2DR)ExperimentalPrezista \& Norvir \& Tivicay
Receives: Drug: Prezista; Drug: Norvir; Drug: Tivicay
B: bDRV plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs; 3DR)Active comparatorPrezista \& Norvir \& Truvada or Prezista \& Norvir \& Kivexa or Prezista \& Norvir \& Descovy
Receives: Drug: Prezista; Drug: Norvir; Drug: Truvada; Drug: Kivexa; Drug: Descovy

What is being measured

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

  1. number (%) of patients with fully suppressed HIV RNA < 50 cps/ml at week 48

    For primary endpoint, HIV RNA suppression < 50 cps/ml will be assessed at week 48, using NAT diagnostic.

    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 posted1 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion31 May 2018
  4. Study completion31 May 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02486133
Sponsor's protocol ID
DUA-1463-SPI-0320-I
Acronym
Dualis
Status last verified
Apr 2019
First submitted
15 Jun 2015
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prezista, Norvir and Tivicay in people with HIV-Infection, run by Technical University of Munich at 1 site in Germany.

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 13 inclusion and 13 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 29 Nov 2023. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

number (%) of patients with fully suppressed HIV RNA < 50 cps/ml at week 48 (time frame: 48 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 NCT02486133.

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 29 Nov 2023.

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