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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDF/3TC/EFV Treatment HIV/HBV Co-infection | Experimental | TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regimen:TDF+3TC+EFV | Drug | TDF+3TC+EFV for HIV/HBV co-infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 | HIV and HBV viral load decreases in patients taking the regimen | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of targeted adverse events over 48 weeks | Clinical and laboratory safety(liver, renal, hematologic)of TDF+3TC+EFV for HIV/HBV co-infected patients | week 12,24,48 |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ cell count increase at week 48 | CD4+ cell count increases in patients receving the regimen | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fujie ZHANG, MD | National Center for AIDS/STD Control and Prevention, China CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for AIDS/STD Control and Prevention, China CDC | Beijing | Beijing Municipality | 102206 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | G Matthews, A Avihingsanon, S Lewin, and others. Tenofovir-based Highly Active Antiretroviral Therapy (HAART) is associated with high rates of HBV DNA suppression and HBeAg seroconversion in Thai HIV-HBV coinfected patients. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 907. O Lada, A Gervais, M Branger, and others. De Novo Combination Therapy of Tenofovir Disoproxil Fumarate (TDF) Plus Lamivudine (LAM) or TDF Plus Emtricitabine (FTC) Is Associated With Early Virologic Response in HIV/HBV Co-Infected Patients. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 922. | ||
| 26831232 | Derived | Wu YS, Zhang WW, Ling XM, Yang L, Huang SB, Wang XC, Wu H, Cai WP, Wang M, Wang H, Liu YF, He HL, Wei FL, Wu ZY, Zhang FJ. Efficacy and Safety of Tenofovir and Lamivudine in Combination with Efavirenz in Patients Co-infected with Human Immunodeficiency Virus and Hepatitis B Virus in China. Chin Med J (Engl). 2016 Feb 5;129(3):304-8. doi: 10.4103/0366-6999.174509. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |