Dolutegravir Plus Lamivudine Simplified Therapy

Sponsor

Guangzhou 8th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03884673

Collaborator

Shenzhen Third People's Hospital (Other), Dongguan People's Hospital (Other), Fifth Affiliated Hospital, Sun Yat-Sen University (Other), The Third People's Hospital of Guilin (Other), Guangxi Longtan hospital (Other), The Fourth People's Hospital of Nanning (Other), The Third People's Hospital of Kunming (Other), Yunnan AIDS Care Center (Other), Meng Chao Hepatobiliary Hospital of Fujian Medical University (Other), First Affiliated Hospital of Guangxi Medical University (Other)

300

Enrollment

Location

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS	Drug: DTG+ 3TC

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
DTG+3TC 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 Names: A simplified therapy regimen

Arm

Intervention/Treatment

DTG+3TC

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 Names:

A simplified therapy regimen

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age (> 18 years), male and female;
HIV-1 infected;
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;
Initial HIV-1 RNA viral load and CD4 cell count were unlimited.
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.
State Informed Consent for Free Treatment has been signed;
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:

Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months;
Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.).
Has a clear history of DTG or 3TC allergy;
HBsAg and/or HBV-DNA positive;
Pregnancy during the study period.