Observing simplified HIV treatment in China
A Simplified Therapy Regimen Study of Lopinavir and Ritonavir Combined With Lamivudine for HIV-1 Infected Patients in the Real World of China
This study is testing a simpler HIV treatment plan to see if it helps people in China stick to their medication and stay healthy over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guangzhou 8th People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03603977 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of a simplified therapy regimen for HIV-1 infected patients in a real-world setting in China. A total of 600 participants will receive a combination of lopinavir/ritonavir and lamivudine over a 36-month period. The study will monitor viral inhibition rates, changes in CD4 cell counts, safety, and patient compliance through follow-ups at 12, 24, and 36 months. The approach focuses on simplifying treatment to improve adherence and outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates include HIV-1 infected individuals who agree to a simplified therapy regimen and can commit to regular CD4 count monitoring.
Not a fit: Patients with a history of resistance or allergy to the study medications, or those unable to complete follow-up, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and manageable treatment options for HIV patients.
How similar studies have performed: Other studies have shown promise in simplifying HIV treatment regimens, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. HIV-1 infection confirmed 2. Agree to use simplified therapy regimen. 3. Agree to detect CD4 count at least once per half a year Exclusion Criteria: 1. Have participated in HIV vaccine clinical trial or other drug trials in the past three months. 2. Patients who could not complete the scheduled follow-up (such as weakness and poor compliance). 3. Patients who have the history of resistance or allergy to LPV/r or 3TC.
Where this trial is running
Guangzhou, Guangdong
- Guangzhou 8th People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Linghua Li, Doctor
- Email: llheliza@126.com
- Phone: 020-83710825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.