Dolutegravir Plus Lamivudine Simplified Therapy

ConditionHIV/AIDS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangzhou 8th People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • DTG+ 3TC

Treatment groups

300 Participants
are divided into 1 treatment group

Sponsors and collaborators

Guangzhou 8th People's Hospital

Lead sponsor

Shenzhen Third People's Hospital

Collaborator

Dongguan People's Hospital

Collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

The Third People's Hospital of Guilin

Collaborator

Guangxi Longtan hospital

Collaborator

The Fourth People's Hospital of Nanning

Collaborator

The Third People's Hospital of Kunming

Collaborator

Yunnan AIDS Care Center

Collaborator

Meng Chao Hepatobiliary Hospital of Fujian Medical University

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator