Dolutegravir Plus Lamivudine Simplified Therapy
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|ClinicalTrials.gov Identifier: NCT03884673|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : June 6, 2019
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.
|Condition or disease||Intervention/treatment|
|HIV/AIDS||Drug: DTG+ 3TC|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
These cases were given simplified therapy regimen including DTG (50 mg, oral,qd) combined with 3TC (300 mg,oral,qd).
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.
Other Name: A simplified therapy regimen
- Virus suppression rate [ Time Frame: 96 weeks ]ratio of HIV RNA < 50 copies/mL at 48 and 96 weeks of treatment
- Adverse events [ Time Frame: 96 weeks ]Rate of adverse events reported during the observational period
- The immunological ability (CD4+) [ Time Frame: 96 weeks ]CD4 cell count (baseline to 48 weeks and 96 weeks)
- Drug compliance [ Time Frame: 96 weeks ]To explicit the number of people who have completed the treatment
- The immunological ability (CD8+) [ Time Frame: 96 weeks ]CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884673
|Contact: Linghua Li, PhDemail@example.com|
|Contact: Weiping Cai, Bachelorfirstname.lastname@example.org|
|Guangzhou 8th People's Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Linghua Li, PhD 020-83710825 email@example.com|
|Principal Investigator:||Weiping Cai, Bachelor||Guangzhou 8th People's Hospital|