Clinical trial NCT01751555: Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
Official title: A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hiv
Keywords: HBV co-infection ART TDF
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
Collaborators: name: Gilead Sciences
First posted: 2012-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48
timeFrame: one year
Secondary outcomes:
measure: Incidence of targeted adverse events over 48 weeks
timeFrame: week 12,24,48
Other outcomes:
measure: CD4+ cell count increase at week 48
timeFrame: one year
Locations:
city: Beijing
country: China
facility: National Center for AIDS/STD Control and Prevention, China CDC
state: Beijing
Study officials:
affiliation: National Center for AIDS/STD Control and Prevention, China CDC
name: Fujie ZHANG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.