HIV-1-infectionPhase 4NCT05506605
Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance
A Phase 4 study testing Doravirine 100Mg Tab in people with HIV-1-infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Phase IV, open-label, single arm, unicenter and pilot study on virologically suppressed HIV infected adults with ETR resistance, to assess the efficacy of a Switch strategy from Etravirine (ETR) to Doravirine (DOR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Doravirine 100Mg Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2022to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1-infected subjects with age ≥18 years old.
- Desire of the patient to simplify their ART-regimen.
- Having plasma HIV-1 RNA < 50 copies/mL during at least the previous 24 weeks.
- Currently receiving an ETR-containing regimen (unchanged during the previous 24 weeks).
- Documented pooled/historical genotype or GRT in pro-viral DNA must show the presence of 103N and/or 181C and/or 190A and/or 100I and/or 138K/A.
Who cannot join
- Documented pooled/historical genotype or GRT in pro-viral DNA of any DOR-DRM (Mutations V106A, Y188L, and M230L, and combinations of V106A and L234I; V106A and F227L and L234I; and V106A and 190A and F227L).
- Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods, for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.
- Active tuberculosis infection.
- Any clinical condition or therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single-arm, Unicenter and Pilot Study of a Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance
Phase IV, open-label, single arm, unicenter and pilot study on virologically suppressed HIV infected adults with ETR resistance, to assess the efficacy of a Switch strategy from Etravirine (ETR) to Doravirine (DOR).
- Conditions
- HIV-1-infection
- Being tested
- Doravirine 100Mg Tab
- Keywords
- HIV, Doravirine, Etravirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doravirine 100Mg TabDrug
Switch from Etravirine to Doravirine
| Study group | Role | What they receive |
|---|---|---|
| Switch from Etravirine to Doravirine | Experimental | Switch from etravirine to Doravirine (Pifeltro) 100 mg each day Receives: Drug: Doravirine 100Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with confirmed HIV viral load>50 copies/mL
Measured by blood HIV viral load
Measured: at week 24
Secondary outcomes (8)
Percentage of participants with HIV viral load>50 copies/mL
Measured by blood HIV viral load
Measured: at week 12 and 48
Percentage of participants with HIV viral load<50 copies/mL
Measured by blood HIV viral load
Measured: at week 12, 24 and 48
Changes in CD4, CD8 cell counts and ratio CD4/CD8
Measured by blood CD4, CD8 and CD/4/CD8 ratio
Measured: at 48 weeks
Incidence of Treatment-Emergent adverse events and serious adverse events
Measured by numer of AEs and SAEs related to the treatment
Measured: at week 48
AUC during the dose interval (AUC0-24) of DRV/r and DRV/c with DOR
Measured: at weeks 2 and 4
Maximum concentrations (Cmax) of DRV/r and DRV/c with DOR
Measured: at weeks 2 and 4
Concentrations at the end of the dosing interval (C24) of DRV/r and DRV/c with DOR
Measured: at weeks 2 and 4
Elimination half-life (t1/2) of DRV/r and DRV/c with DOR
Measured: at weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start12 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506605
- Sponsor's protocol ID
- DoRSwitch.21
- Status last verified
- Sep 2023
- First submitted
- 22 Jul 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm, Unicenter and Pilot Study of a Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance
- ClinicalTrials.gov ID
- NCT05506605
- Acronym / sponsor ID
- DoRSwitch.21
- Conditions
- HIV-1-infection
- Keywords
- HIV, Doravirine, Etravirine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Aug 2022 (actual)
- 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.
Phase IV, open-label, single arm, unicenter and pilot study on virologically suppressed HIV infected adults with ETR resistance, to assess the efficacy of a Switch strategy from Etravirine (ETR) to Doravirine (DOR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switch from Etravirine to Doravirine | Experimental | Drug: Doravirine 100Mg TabSwitch from etravirine to Doravirine (Pifeltro) 100 mg each day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1-infected subjects with age ≥18 years old.
- Desire of the patient to simplify their ART-regimen.
- Having plasma HIV-1 RNA < 50 copies/mL during at least the previous 24 weeks.
- Currently receiving an ETR-containing regimen (unchanged during the previous 24 weeks).
- Documented pooled/historical genotype or GRT in pro-viral DNA must show the presence of 103N and/or 181C and/or 190A and/or 100I and/or 138K/A.
Key exclusion criteria (4 listed)
- Documented pooled/historical genotype or GRT in pro-viral DNA of any DOR-DRM (Mutations V106A, Y188L, and M230L, and combinations of V106A and L234I; V106A and F227L and L234I; and V106A and 190A and F227L).
- Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods, for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.
- Active tuberculosis infection.
- Any clinical condition or therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements.
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 |
|---|---|---|
| Doravirine 100Mg TabSwitch from Etravirine to Doravirine | Drug | Switch from Etravirine to Doravirine |
Primary outcome
Percentage of participants with confirmed HIV viral load>50 copies/mL
Time frame: at week 24
Measured by blood HIV viral load
8 secondary outcomes
Percentage of participants with HIV viral load>50 copies/mL
Time frame: at week 12 and 48
Percentage of participants with HIV viral load<50 copies/mL
Time frame: at week 12, 24 and 48
Changes in CD4, CD8 cell counts and ratio CD4/CD8
Time frame: at 48 weeks
Incidence of Treatment-Emergent adverse events and serious adverse events
Time frame: at week 48
AUC during the dose interval (AUC0-24) of DRV/r and DRV/c with DOR
Time frame: at weeks 2 and 4
Maximum concentrations (Cmax) of DRV/r and DRV/c with DOR
Time frame: at weeks 2 and 4
Concentrations at the end of the dosing interval (C24) of DRV/r and DRV/c with DOR
Time frame: at weeks 2 and 4
Elimination half-life (t1/2) of DRV/r and DRV/c with DOR
Time frame: at weeks 2 and 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Doravirine 100Mg Tab in people with HIV-1-infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 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 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?
Results are not available in the source record.
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 participants with confirmed HIV viral load>50 copies/mL (time frame: at week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.