Combination of Dolutegravir and Lamivudine for HIV Treatment

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

This study is testing whether a simpler two-drug treatment for HIV can work just as well and be safe for people who have been on a three-drug regimen.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangzhou 8th People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03884673 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are HIV-1 infected adults over 18 years who have been on a standard three-drug regimen for at least 24 weeks and are eligible for a simplified treatment due to various clinical reasons.

Not a fit: Patients who are not HIV-1 infected or those who have contraindications to the use of DTG and 3TC will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective and tolerable treatment option for HIV patients, potentially improving adherence and health outcomes.

How similar studies have performed: Other studies have shown promising results with similar simplified two-drug regimens, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• 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

Conditions HIV/AIDS; DTG + 3TC Simplified Therapy; Simplified Therapy Regimen; Real World Study; HIV-1-infected patients