Combination of Dolutegravir and Lamivudine for HIV Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the efficacy and safety of a simplified two-drug regimen consisting of dolutegravir (DTG) and lamivudine (3TC) in HIV-infected patients. Conducted in a real-world clinical setting, the study involves 300 participants who have been on a standard three-drug regimen for at least 24 weeks and are transitioning to the simplified treatment. The study monitors viral suppression rates and CD4 cell counts at multiple time points over 96 weeks, while also assessing safety and patient compliance. The goal is to provide data that could inform clinical guidelines for simplified HIV treatment regimens in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangzhou 8th People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Weiping Cai, Bachelor — Guangzhou 8th People's Hospital
• Study coordinator: Linghua Li, PhD
• Email: llheliza@126.com
• Phone: 020-83710825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.