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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|