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Dolutegravir Plus Lamivudine Simplified Therapy

NCT03884673 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-09-14

No results posted yet for this study

Summary

Dolutegravir (DTG) is one type of integrase inhibitor, lamivudine (3TC) is one type of reverse transcriptase inhibitor, both of which are HIV medicine prevents HIV from self-multiplying, reduces the viral load. The data of the existing randomized controlled clinical studies show that the simplified two-drug DTG-based regimen is similar to the three-drug regimen in terms of efficacy, but there are no relevant data and reports on the efficacy and safety of DTG+3TC in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of the DTG + 3TC regimen for HIV-infected patients in real clinical environment, to guide clinical application, and to provide a theoretical basis for the selection of simplified schemes for the formulation of guidelines.

This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV.

Conditions

Interventions

DRUG

DTG+ 3TC

It is a simplified therapy regimen study of dolutegravir combined with lamivudine for HIV-1 infected patients in the real world of China.

Sponsors & Collaborators

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • The Third People's Hospital of Guilin

    collaborator UNKNOWN

  • Guangxi Longtan hospital

    collaborator UNKNOWN

  • The Fourth People's Hospital of Nanning

    collaborator OTHER

  • The Third People's Hospital of Kunming

    collaborator UNKNOWN

  • Yunnan AIDS Care Center

    collaborator OTHER

  • Meng Chao Hepatobiliary Hospital of Fujian Medical University

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Guangzhou 8th People's Hospital

    lead OTHER

Principal Investigators

  • Weiping Cai, Bachelor · Guangzhou 8th People's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2025-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884673 on ClinicalTrials.gov