HIV/AIDS
Conditions
Keywords
DTG + 3TC Simplified Therapy, Simplified Therapy Regimen, Real World Study, HIV-1-infected patients
Brief 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.
Detailed description
This study is an open-label, multicentered, single-arm and phase IV clinical trial. 300 HIV-infected patients who received simplified treatment regimen (50mg DTG+ 400mg 3TC, oral, qd) were selected to observe the treatment efficacy. At week 24, 36, 48 and 96, the rate of viral suppression and CD4 cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored.
Interventions
DRUGDTG+ 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
Shenzhen Third People's Hospital
Dongguan People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
The Third People's Hospital of Guilin
Guangxi Longtan hospital
The Fourth People's Hospital of Nanning
The Third People's Hospital of Kunming
Yunnan AIDS Care Center
Meng Chao Hepatobiliary Hospital of Fujian Medical University
First Affiliated Hospital of Guangxi Medical University
Guangzhou 8th People's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age (\> 18 years), male and female; 2. HIV-1 infected; 3. Using a standard three-drug-based regimen for at least 24 weeks. Based on clinical decision making\* decide if patients can be treated with the DTG+3TC simplified scheme for a variety of reasons, such as (but not limited to): patients cannot tolerate the conventional three-drug treatment scheme, renal insufficiency, osteoporosis, bone marrow suppression and for other reasons patients cannot use the conventional three-drug treatment scheme; 4. Initial HIV-1 RNA viral load and CD4 cell count were unlimited. 5. CD4 can be monitored at least three times in the first year (including baseline, 24 weeks of treatment and 48 weeks of treatment). After the first year, CD4 can be detected at least once every six months. 6. State Informed Consent for Free Treatment has been signed; 7. Good compliance and signing Informed Consent (\* Reference criteria: Refer to APSIRE study, creatinine clearance rate (\> 50 mL/min), no DTG/3TC allergy history, HBsAg negative, no chronic liver disease, no severe liver damage, no pregnancy during the study)
Exclusion criteria
1. Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months; 2. Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.). 3. Has a clear history of DTG or 3TC allergy; 4. HBsAg and/or HBV-DNA positive; 5. Pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virus suppression rate | 96 weeks | ratio of HIV RNA \< 50 copies/mL at 48 and 96 weeks of treatment |
| Adverse events | 96 weeks | Rate of adverse events reported during the observational period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The immunological ability (CD4+) | 96 weeks | CD4 cell count (baseline to 48 weeks and 96 weeks) |
| Drug compliance | 96 weeks | To explicit the number of people who have completed the treatment |
| The immunological ability (CD8+) | 96 weeks | CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks) |
Countries
China
Contacts
Primary ContactLinghua Li, PhD
Backup ContactWeiping Cai, Bachelor
Outcome results
None listed