HIV-1-infectionNCT05332470
A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients
An observational study of HIV-1-infection, run by Peking Union Medical College Hospital.
Trial summary
Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato(Dolutegravir/lamivudine) as an initial treatment in HIV-naÏve patients. However there is no real- life data. 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?
- Lamivudine and Dotiravir Sodium Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the treatment-naïve HIV-1 infected patients
Who may be able to join
- Understand and sign the written informed consent ;
- Over 18 years old;
- Western Blot test confirmed HIV positive, and did not take any antiretroviral therapy;
- HIV viral load ≥1000 copies/ml ;
- Uncomplicated hepatitis B virus infection: HBsAg (-) ;
- Estimated glomerular filtration rate (GFR) > 30ml/min (calculated by CKD - EPI);
- No serious liver function damage (Child C ) ;
- Be able to carry out antiviral treatment and regular follow-up according to the plan.
Who cannot join
- Previously used ART or used PreP or PEP ;
- Have a history of mental or nervous system diseases or suicidal tendencies;
- Severe cardiovascular and respiratory system diseases, liver and kidney function damage, coagulation dysfunction, thrombocytopenia, circulatory system diseases, etc.;
- There are indications of glucocorticoid application during application or follow-up period;
- Radiotherapy, chemotherapy, cell therapy or therapeutic vaccine, immunomodulatory therapy, etc. are required within 28 days before the start of the study or during the study period;
- Participate in other drug trials;
- Those who are pregnant, breastfeeding or planning to become pregnant within one year;
- Poor compliance, unable to follow up on schedule.
Trial locations and contacts
No sites are listed yet.
About this study
Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato(Dolutegravir/lamivudine) as an initial treatment in HIV-naÏve patients. However there is no real- life data. The investigators' results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with DTG (dolutegravir) + 3TC(lamivudine ), to verify efficacy and tolerance in real life. The investigators' hypothesis is that the data will be similar to those reported in clinical trials.
Read the detailed description
Since 1996, HAART(Highly Active Antiretroviral Therapy) based on 3DR(3-drug regimens ) in PLHIV(people living with HIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. However PLHIV needs to continue the treatment and will likely remain on antiviral therapy for many years. In the recent period, active research is being sought with the aim of improving the dosage and reducing the amount of drugs necessary to maintain efficacy, to avoid the possible cumulative effects of long-term ART (antiretroviral therapy). 2DRs(Two-drug regimens) have been investigated as a means for reducing the number of ARVs(antiretroviral agents) taken by individuals who need lifelong ART. Dovato has been evaluated in two phase III studies (GEMINI-1 and GEMINI-2) in treatment-naive adults achieving non inferiority according to the US FDA (Food and Drug Administration) Snapshot algorithm. These data led to the approval of the fixed-dose combination of dolutegravir/lamivudine as a once-daily, single-tablet 2DR by the FDA and the European Medicines Agency. Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato as an initial treatment in HIV-naÏve patients. However there is no real- life data. The investigators' aim is to provide information related to effectiveness and tolerability/safety in naïve patients when used in routine clinical practice. It has been already published results from the phase III study in pretreatment adult patients.
The investigators' results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with DTG (dolutegravir) + 3TC(lamivudine ), to verify efficacy and tolerance in real life. The investigators' hypothesis is that the data will be similar to those reported in clinical trials.
- Conditions
- HIV-1-infection
- Being tested
- Lamivudine and Dotiravir Sodium Tablets
- Keywords
- Lamivudine and Dotiravir Sodium Tablets, Dovato
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine and Dotiravir Sodium TabletsDrug
Also called Dovato
3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h)
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals with HIV-1 RNA <50 copies/ml at 24 weeks
Proportion of individuals with HIV-1 RNA <50 copies/ml at 24 weeks
Measured: 24 weeks
Secondary outcomes (1)
Proportion of individuals with HIV-1 RNA <50 copies/ml at 48 weeks
Proportion of individuals with HIV-1 RNA <50 copies/ml at 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion31 May 2025 (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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WEI Lyu, Principal investigator, Department of Infectious Diseases, PekingUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332470
- Sponsor's protocol ID
- PekingUMCH record ZS-3419D
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT05332470
- Acronym / sponsor ID
- PekingUMCH record ZS-3419D
- Conditions
- HIV-1-infection
- Keywords
- Lamivudine and Dotiravir Sodium Tablets, Dovato
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 18 Apr 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.
Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato(Dolutegravir/lamivudine) as an initial treatment in HIV-naÏve patients. However there is no real- life data. The investigators' results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with DTG (dolutegravir) + 3TC(lamivudine ), to verify efficacy and tolerance in real life. The investigators' hypothesis is that the data will be similar to those reported in clinical trials.
Detailed description
Since 1996, HAART(Highly Active Antiretroviral Therapy) based on 3DR(3-drug regimens ) in PLHIV(people living with HIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. However PLHIV needs to continue the treatment and will likely remain on antiviral therapy for many years. In the recent period, active research is being sought with the aim of improving the dosage and reducing the amount of drugs necessary to maintain efficacy, to avoid the possible cumulative effects of long-term ART (antiretroviral therapy). 2DRs(Two-drug regimens) have been investigated as a means for reducing the number of ARVs(antiretroviral agents) taken by individuals who need lifelong ART. Dovato has been evaluated in two phase III studies (GEMINI-1 and GEMINI-2) in treatment-naive adults achieving non inferiority according to the US FDA (Food and Drug Administration) Snapshot algorithm. These data led to the approval of the fixed-dose combination of dolutegravir/lamivudine as a once-daily, single-tablet 2DR by the FDA and the European Medicines Agency. Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato as an initial treatment in HIV-naÏve patients. However there is no real- life data. The investigators' aim is to provide information related to effectiveness and tolerability/safety in naïve patients when used in routine clinical practice. It has been already published results from the phase III study in pretreatment adult patients.
The investigators' results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with DTG (dolutegravir) + 3TC(lamivudine ), to verify efficacy and tolerance in real life. The investigators' hypothesis is that the data will be similar to those reported in clinical trials.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the treatment-naïve HIV-1 infected patients
Key inclusion criteria (8 listed)
- Understand and sign the written informed consent ;
- Over 18 years old;
- Western Blot test confirmed HIV positive, and did not take any antiretroviral therapy;
- HIV viral load ≥1000 copies/ml ;
- Uncomplicated hepatitis B virus infection: HBsAg (-) ;
Key exclusion criteria (8 listed)
- Previously used ART or used PreP or PEP ;
- Have a history of mental or nervous system diseases or suicidal tendencies;
- Severe cardiovascular and respiratory system diseases, liver and kidney function damage, coagulation dysfunction, thrombocytopenia, circulatory system diseases, etc.;
- There are indications of glucocorticoid application during application or follow-up period;
- Radiotherapy, chemotherapy, cell therapy or therapeutic vaccine, immunomodulatory therapy, etc. are required within 28 days before the start of the study or during the study period;
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 |
|---|---|---|
| Lamivudine and Dotiravir Sodium TabletsAlso: Dovato3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h) | Drug | – |
Primary outcome
Proportion of individuals with HIV-1 RNA <50 copies/ml at 24 weeks
Time frame: 24 weeks
Proportion of individuals with HIV-1 RNA <50 copies/ml at 24 weeks
1 secondary outcome
Proportion of individuals with HIV-1 RNA <50 copies/ml at 48 weeks
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- 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.
WEI Lyu principal investigator
Department of Infectious Diseases, PekingUMCH
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Peking Union Medical College Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 QING ZHANG (15001278131 ext. +86, zhangqingpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals with HIV-1 RNA <50 copies/ml at 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?
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 18 Apr 2022.