AIDS/HIV PROBLEM
Conditions
Brief summary
This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.
Detailed description
This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population. 500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 \< 250/μL, and by LPV/r when CD4 \> 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb \< 90/L or neutrophil count \< 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years. The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.
Interventions
DRUGTDF+3TC+EFV
Sponsors
Peking Union Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age between 18-65 years of either gender * HIV-1 antibody seropositive detected by ELISA and confirmed by western blot * CD4 cell count \< 500/ul * Signed informed consent, with no condition that precludes follow-up for 2 years * No plan to move out of the area during the trial * antiretroviral therapy naive
Exclusion criteria
* patients in acute phase of HIV infection * patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion * patients with the any of the following test results during screening for inclusion: * WBC count \< 2000/ul, * neutrophil count \< 1000/ul, * Hb \< 9g/dl, * platelet count \< 75000/ul, * serum creatinine \> 1.5 ULN, * transaminases or alkaline phosphatase \> 3 ULN, * total bilirubin \> 2 ULN, * serum creatinine kinase \> 2 ULN * CCr \< 60ml/min * Pregnancy and breastfeeding * Intravenous drug user * Severe neuropathy or mental disorder * history of alcohol abuse and unable to withdrawal * Severe peptic ulcer disease * Non-Chinese nationality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 | 96 weeks |
| Change From Baseline in CD4 count at Week 48 | Baseline and 48 weeks |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | 96 weeks |
| Incidence of adverse events and laboratory abnormalities from baseline to week 48 | 48 weeks |
| Incidence of adverse events and laboratory abnormalities from baseline to week 96 | 96 weeks |
| Change From Baseline in CD4 count at Week 96 | Baseline and 96 weeks |
Countries
China
Contacts
Primary ContactTai sheng Li, MD
Outcome results
None listed