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
This trial does not accept healthy volunteersQualifiers
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 population
Patients who are prescribed to take the simplified therapy regimen (DTG+ 3TC) because they are unable to tolerate the side-effect of or are not fit for the first-line free regimen in China, for example renal failure or osteoporosis, according to clinical judgment, no matter of the HIV-RNA viral loads and CD4 cell counts.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
DTG+ 3TC
DrugIt is a simplified therapy regimen study of dolutegravir combined with lamivudine for HIV-1 infected patients in the real world of China.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: DTG+3TC1 intervention
Trial outcomes
Primary outcomes
1
Virus suppression rate
ratio of HIV RNA \< 50 copies/mL at 48 and 96 weeks of treatment
Time frame
96 weeks2
Adverse events
Rate of adverse events reported during the observational period
Time frame
96 weeksSecondary outcomes
1
The immunological ability (CD4+)
CD4 cell count (baseline to 48 weeks and 96 weeks)
Time frame
96 weeks2
Drug compliance
To explicit the number of people who have completed the treatment
Time frame
96 weeks3
The immunological ability (CD8+)
CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks)
Time frame
96 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov