Actively Recruiting
Dolutegravir Plus Lamivudine Simplified Therapy
Led by Guangzhou 8th People's Hospital · Updated on 2022-09-14
300
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
Sponsors
G
Guangzhou 8th People's Hospital
Lead Sponsor
S
Shenzhen Third People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dolutegravir Plus Lamivudine Simplified Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years, male or female
- Diagnosed with HIV-1 infection
- Have used a standard three-drug HIV regimen for at least 24 weeks
- Eligible for switching to DTG+3TC simplified therapy based on clinical judgment (e.g., intolerance to three-drug regimen, kidney problems, osteoporosis, bone marrow suppression)
- Initial HIV-1 RNA viral load and CD4 cell count have no limits
- Able to monitor CD4 cell count at least three times in the first year (including baseline, 24 weeks, and 48 weeks) and at least once every six months after the first year
- Signed informed consent for free treatment
- Demonstrate good treatment compliance and signed informed consent
You will not qualify if you...
- Participated in other HIV vaccine or drug clinical trials within the past three months
- Considered unlikely to complete scheduled follow-up due to poor health or compliance
- Known allergy to dolutegravir (DTG) or lamivudine (3TC)
- Positive for hepatitis B surface antigen (HBsAg) or HBV-DNA
- Pregnant during the study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangzhou 8th People's Hospital
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
L
Linghua Li, PhD
CONTACT
W
Weiping Cai, Bachelor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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