Actively Recruiting
Led by Guangzhou 8th People's Hospital · Updated on 2022-09-14
300
Participants Needed
1
Research Sites
260 weeks
Total Duration
G
Guangzhou 8th People's Hospital
Lead Sponsor
S
Shenzhen Third People's Hospital
Collaborating Sponsor
Researchers are evaluating a simplified treatment for HIV using a combination of two anti-HIV medicines, dolutegravir (DTG) and lamivudine (3TC), taken once daily. This study aims to explore the safety and effectiveness of this two-drug regimen in HIV-infected patients in China, as previous studies have shown similar results compared to traditional three-drug treatments but lack data from the Chinese population. The goal is to guide clinical use and provide a solid basis for treatment guidelines. This open-label, phase IV clinical trial involves 300 HIV-infected patients who switch to a simplified regimen of 50 mg DTG plus 400 mg 3TC taken orally once daily. The study observes the treatment's effectiveness by measuring viral suppression rates and immune cell counts at weeks 24, 36, 48, and 96. Safety and medication adherence are also monitored throughout the trial. Participants will have their viral load and CD4/CD8 immune cell counts assessed regularly over 96 weeks, along with monitoring for any adverse events and treatment compliance. The study involves multiple follow-up visits to track immune function changes and viral control. This long-term observation provides valuable data on how well the simplified therapy works and how safe it is for patients living with HIV.
CONDITIONS
Dolutegravir Plus Lamivudine Simplified Therapy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 96 weeks
Participants receive a simplified therapy regimen of dolutegravir combined with lamivudine for HIV-1 infection.
Visits at Week 24, 36, 48, and 96 to monitor viral suppression, CD4 and CD8 cell counts, safety, and drug compliance
Total: 1 location
1
Guangzhou 8th People's Hospital
Guangzhou, Guangdong, China, 510060
Actively Recruiting
L
Linghua Li, PhD
W
Weiping Cai, Bachelor
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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