Hiv
Conditions
Keywords
HBV co-infection ART TDF
Brief summary
This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human immunodeficiency virus-1 and hepatitis B virus coinfection.
Detailed description
HIV/HBV co-infections are frequently observed due to shared routes of transmission. TDF and 3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases. There is higher risk to cause drug resistance in treating HBV or HIV infection with 3TC or TDF monotherapy than combination trerapy. Combination tharapy could decreases drug resistance. China's HIV epidemic remains one of low prevalence overall, but with pockets of high infection among specific sub-populations and in some localities. China has a very high endemicity for hepatitis B too. A substantial proportion of HIV-infected individuals are co-infected with HBV. TDF + 3TC + EFV will be a common regimen for HIV/HBV co-infected Chinese individuals. The purpose of this study of this study is to determine whether TDF will be safe for patients with HIV and HBV co-infection and the combination of TDF+3TC+EFV will suppress HIV and HBV viral load below LDL at week 48 of treatment in patients with HIV and HBV co-infeciton.This study will enroll 100 adult subjects and follow these patients for 48 weekes.There will be one enrollment visit(baseline) and visits at 2,4,8,12,24,36,48 weeks after initiation of the study regimen.
Interventions
DRUGRegimen:TDF+3TC+EFV
TDF+3TC+EFV for HIV/HBV co-infection
Sponsors
Gilead Sciences
National Center for AIDS/STD Control and Prevention, China CDC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Serologically-confirmed HIV and HBV infection * Willingness to participate in a clinical trial * No previous or current use of antiretroviral regimen * Clinical conditions stable * Blood creatinine less than 3 times the upper limit of normal values. HBV DNA\>1000copies/ml, Tbil\<34umol/L,ALT\<400U/L * With clinical indications for HAART
Exclusion criteria
* Patient refuses to sign the consent to participate * Unwillingness to adhere to visit schedule or maintain adherence with medications * Illnesses so serve as to likely require hospitalization * With other conditions that not suitable to be enrolled will be subject to medical review
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 | one year | HIV and HBV viral load decreases in patients taking the regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of targeted adverse events over 48 weeks | week 12,24,48 | Clinical and laboratory safety(liver, renal, hematologic)of TDF+3TC+EFV for HIV/HBV co-infected patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| CD4+ cell count increase at week 48 | one year | CD4+ cell count increases in patients receving the regimen |
Countries
China
Outcome results
None listed