AIDS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected ART-native patients; 2. at least 18 years old; 3. plasma HIV-1 RNA level of more than 1000 copies/ml and CD4+ cell count over 200 cells/mm3.
Exclusion criteria
Exclusion criteria: 1. Patients who were pregnant or breastfeeding; 2. co-infected with HBV or HCV; 3. had chronic liver disease, or had active AIDS-associated opportunistic diseases within 30 days after screening; 4. had poor adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with plasma HIV-1 RNA less than 50 copies/ml at week 144; | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of patients with plasma HIV-1 RNA concentration less than 400 copies/ml at week 144, change in CD4+ cell count, ratio of CD4+ and CD8+ , safety, tolerability, resistance analysis in patients with virological failure, and changes of chronic immune activation indicators; | — |
Countries
China
Contacts
Guangzhou Eighth People's Hospital