NCT03884673Recruiting
Dolutegravir Plus Lamivudine Simplified Therapy
Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients
Source: ClinicalTrials.gov · Last updated 14 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 18 Mar 2019
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Guangzhou 8th People's Hospital
- Diseases
- HIV
- NCT number
- NCT03884673
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Jan 2019 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months;
- Has a clear history of DTG or 3TC allergy;
- HBsAg and/or HBV-DNA positive;
Other
- Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.).
- Pregnancy during the study period.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangzhou 8th People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.