A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Lamivudine and Dotiravir Sodium Tablets

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: QING ZHANG; Phone Number: +86 15001278131; Email: zhangqingpumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

the treatment-naïve HIV-1 infected patients

Description

Inclusion Criteria:

1. Understand and sign the written informed consent ;
2. Over 18 years old;
3. Western Blot test confirmed HIV positive, and did not take any antiretroviral therapy;
4. HIV viral load ≥1000 copies/ml ;
5. Uncomplicated hepatitis B virus infection: HBsAg (-) ;
6. Estimated glomerular filtration rate (GFR) > 30ml/min (calculated by CKD - EPI);
7. No serious liver function damage (Child C ) ;
8. Be able to carry out antiviral treatment and regular follow-up according to the plan.

Exclusion Criteria:

1. Previously used ART or used PreP or PEP ;
2. Have a history of mental or nervous system diseases or suicidal tendencies;
3. Severe cardiovascular and respiratory system diseases, liver and kidney function damage, coagulation dysfunction, thrombocytopenia, circulatory system diseases, etc.;
4. There are indications of glucocorticoid application during application or follow-up period;
5. 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;
6. Participate in other drug trials;
7. Those who are pregnant, breastfeeding or planning to become pregnant within one year;
8. Poor compliance, unable to follow up on schedule.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): May 31, 2025

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (ACTUAL): April 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Lamivudine and Dotiravir Sodium Tablets; Dovato
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine
• Other Study ID Numbers: PekingUMCH record ZS-3419D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No