HIVDORAgeNCT05202613
Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (DORAge).
An observational study of HIV, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The HIV-infected population is aging due to the success of combination antiretroviral therapy, which prolongs survival, as well as the growing number of newly diagnosed cases in adults 50 years old and over. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Doravirine
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jan 2022to Dec 2022
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV infected patients
Who may be able to join
- HIV-1 infected patients
- aged > 50 years old
- naive patients receiving doravirine-based regimens both as single drug and as in fixed combination with lamivudine and tenofovir disoproxil fumarate
- experienced patients with persistently undetectable plasma HIV viral load (HIV RNA < 50 copies/mL) for at least 6 months, who switched from any antiretroviral drug to doravirine-based regimens, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate, because of toxicity, convenience or other reasons.
- estimated creatinine clearance (CrCl) ≥50mL/min.
Who cannot join
- previous genotypic testing showing resistance mutations to doravirine
- acute hepatitis, decompensated liver disease, liver cirrhosis
- use of systemic immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Public Health and Infectious Diseases
Rome, Italy/RM, 00185
Gabriella d'Ettorre, Professor, MD, 0649970801, gabriella.dettorre@uniroma1.it
About this study
The HIV-infected population is aging due to the success of combination antiretroviral therapy, which prolongs survival, as well as the growing number of newly diagnosed cases in adults 50 years old and over. This real-life, observational and retrospective study aims to evaluate the virological efficacy, toxicity and tolerability of Doravirine-based regimens in aged HIV-1 positive patients (> 50 years), focusing on metabolic patterns and inflammation markers.
Read the detailed description
HIV-infected individuals suffer from an accelerated aging due to the persistent and chronic activation of the immune system that leads to immune exhaustion and accelerated immunosenescence. The success of combination antiretroviral therapy, which also prolongs patients' survival, have relatively higher retention rates among HIV infected elderly patients, but only a small percentage are virally suppressed, largely due to elderly drugs interacts with ART and several comorbidities that reduces the life span of elderly people.
In this context, Doravirine is the only NNRTI with a low propensity for resistance, excellent tolerability, a superior neuropsychiatric profile compared with EFV, a superior lipid profile compared with ritonavir-boosted darunavir and EFV, minimal risk for drug- drug interactions, and no food restrictions. In addition, doravirine has a large therapeutic index and robust efficacy in patients with high viral load. However, to date, data on doravirine in HIV aged patients are still lacking.
This observational retrospective cohort in real world will aim to describe the effect of doravirine regimens, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate, in aged HIV patients.
- The primary endpoint will be the evaluation of virological efficacy defined as the proportion of patients with HIV RNA < 50 copies/mL at the end of the 48-week follow-up.
- The secondary endpoints will be the following:
- Change in CD4+, CD8 cell counts, CD4/ CD8 ratio from baseline to 48 weeks
- Proportion of patients with any adverse events (AE), serious adverse events (SAE), also according to their severity.
- Changes in total HDL and LDL-cholesterol, triglycerides, creatinine, eGFR, phosphate, AST, ALT, FIB-4, ALP, glucose, proteinuria from baseline to 48 weeks.
- Changes of infiammatory biomarkers: D-Dimer, hsCRP and IL-6 during 48 weeks
- Occurrence of genotypic mutations (genotypic test) in plasma samples from patients with virological failure
Clinical data will be collected from medical records and laboratory analyses comprising CD4+ T cell count, plasma HIV-1 RNA, blood cells, and plasma chemistry profiles, including fasting lipids (total cholesterol, high-density lipoprotein cholesterol [HDL], low- density lipoprotein [LDL] cholesterol, triglycerides) will be recorded.
The Time horizon for patient follow-up for outcome is at least 12 months (Baseline, 12, 24, 36, 48 weeks).
- Conditions
- HIV
- Being tested
- Doravirine
- Keywords
- HIV, Doravirine, Virological Failure, Metabolism, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoravirineDrug
Doravirine, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate
| Study group | Role | What they receive |
|---|---|---|
| Dorage group | * HIV-1 infected patients
* aged > 50 years old
* naive patients receiving doravirine-based regimens
* experienced patients with persistent HIV RNA < 50 copies/mLfor at least 6 months, who switched to doravirine-based regimens, because of toxicity, convenience or other reasons. Receives: Drug: Doravirine | |
| Control group | HIV negative subjects, matched for age and Charlson Index score (to evaluate comorbidity impact) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological efficacy
Assessing the virological efficacy (HIV RNA < 50 copies/mL) of the Doravirine regimen at the end of the follow-up.
Measured: 48 weeks
Secondary outcomes (6)
Time to virological failure
Measured: 48 weeks
Immunological changes
Change in CD4+, CD8 cell counts, CD4/ CD8 ratio
Measured: Baseline to 48 weeks
Safety profile
Proportion of patients with any adverse events (AE), serious adverse events (SAE), also according to their severity.
Measured: Baseline to 48 weeks
Lipid and metabolic profile
Changes in total HDL and LDL-cholesterol, triglycerides, creatinine, eGFR, phosphate, AST, ALT, FIB-4, ALP, glucose, proteinuria
Measured: Baseline to 48 weeks
Infiammatory biomarkers
Evaluation of D-Dimer, hsCRP and IL-6
Measured: 48 weeks
Resistance profile in patients with virological rebound
Evaluation of of genotypic mutations occurrence (genotypic test) in plasma samples from patients with virological failure
Measured: Baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start4 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Gabriella d'Ettorre, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202613
- Sponsor's protocol ID
- 6496
- Acronym
- DORAge
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (DORAge).
- ClinicalTrials.gov ID
- NCT05202613
- Acronym / sponsor ID
- DORAge / 6496
- Conditions
- HIV
- Keywords
- HIV, Doravirine, Virological Failure, Metabolism, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Jan 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.
The HIV-infected population is aging due to the success of combination antiretroviral therapy, which prolongs survival, as well as the growing number of newly diagnosed cases in adults 50 years old and over. This real-life, observational and retrospective study aims to evaluate the virological efficacy, toxicity and tolerability of Doravirine-based regimens in aged HIV-1 positive patients (> 50 years), focusing on metabolic patterns and inflammation markers.
Detailed description
HIV-infected individuals suffer from an accelerated aging due to the persistent and chronic activation of the immune system that leads to immune exhaustion and accelerated immunosenescence. The success of combination antiretroviral therapy, which also prolongs patients' survival, have relatively higher retention rates among HIV infected elderly patients, but only a small percentage are virally suppressed, largely due to elderly drugs interacts with ART and several comorbidities that reduces the life span of elderly people.
In this context, Doravirine is the only NNRTI with a low propensity for resistance, excellent tolerability, a superior neuropsychiatric profile compared with EFV, a superior lipid profile compared with ritonavir-boosted darunavir and EFV, minimal risk for drug- drug interactions, and no food restrictions. In addition, doravirine has a large therapeutic index and robust efficacy in patients with high viral load. However, to date, data on doravirine in HIV aged patients are still lacking.
This observational retrospective cohort in real world will aim to describe the effect of doravirine regimens, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate, in aged HIV patients.
- The primary endpoint will be the evaluation of virological efficacy defined as the proportion of patients with HIV RNA < 50 copies/mL at the end of the 48-week follow-up.
- The secondary endpoints will be the following:
- Change in CD4+, CD8 cell counts, CD4/ CD8 ratio from baseline to 48 weeks
- Proportion of patients with any adverse events (AE), serious adverse events (SAE), also according to their severity.
- Changes in total HDL and LDL-cholesterol, triglycerides, creatinine, eGFR, phosphate, AST, ALT, FIB-4, ALP, glucose, proteinuria from baseline to 48 weeks.
- Changes of infiammatory biomarkers: D-Dimer, hsCRP and IL-6 during 48 weeks
- Occurrence of genotypic mutations (genotypic test) in plasma samples from patients with virological failure
Clinical data will be collected from medical records and laboratory analyses comprising CD4+ T cell count, plasma HIV-1 RNA, blood cells, and plasma chemistry profiles, including fasting lipids (total cholesterol, high-density lipoprotein cholesterol [HDL], low- density lipoprotein [LDL] cholesterol, triglycerides) will be recorded.
The Time horizon for patient follow-up for outcome is at least 12 months (Baseline, 12, 24, 36, 48 weeks).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorage group | – | Drug: Doravirine* HIV-1 infected patients * aged > 50 years old * naive patients receiving doravirine-based regimens * experienced patients with persistent HIV RNA < 50 copies/mLfor at least 6 months, who switched to doravirine-based regimens, because of toxicity, convenience or other reasons. |
| Control group | – | –HIV negative subjects, matched for age and Charlson Index score (to evaluate comorbidity impact) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients
Key inclusion criteria (5 listed)
- HIV-1 infected patients
- aged > 50 years old
- naive patients receiving doravirine-based regimens both as single drug and as in fixed combination with lamivudine and tenofovir disoproxil fumarate
- experienced patients with persistently undetectable plasma HIV viral load (HIV RNA < 50 copies/mL) for at least 6 months, who switched from any antiretroviral drug to doravirine-based regimens, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate, because of toxicity, convenience or other reasons.
- estimated creatinine clearance (CrCl) ≥50mL/min.
Key exclusion criteria (3 listed)
- previous genotypic testing showing resistance mutations to doravirine
- acute hepatitis, decompensated liver disease, liver cirrhosis
- use of systemic immunosuppressive therapy
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 |
|---|---|---|
| DoravirineDoravirine, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate | Drug | Dorage group |
Primary outcome
Virological efficacy
Time frame: 48 weeks
Assessing the virological efficacy (HIV RNA < 50 copies/mL) of the Doravirine regimen at the end of the follow-up.
6 secondary outcomes
Time to virological failure
Time frame: 48 weeks
Immunological changes
Time frame: Baseline to 48 weeks
Safety profile
Time frame: Baseline to 48 weeks
Lipid and metabolic profile
Time frame: Baseline to 48 weeks
Infiammatory biomarkers
Time frame: 48 weeks
Resistance profile in patients with virological rebound
Time frame: Baseline to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of Roma La Sapienza at 1 site in Italy.
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 3 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 Jan 2022. 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 Italy. 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.
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?
Contact Gabriella d'Ettorre, Professor, MD (0649970801, gabriella.dettorre@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virological efficacy (time frame: 48 weeks). 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 Jan 2022.