Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
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ClinicalTrials.gov Identifier: NCT01751555 |
Recruitment Status
:
Completed
First Posted
: December 18, 2012
Last Update Posted
: June 28, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hiv | Drug: Regimen:TDF+3TC+EFV | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: TDF/3TC/EFV Treatment HIV/HBV Co-infection
TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection
|
Drug: Regimen:TDF+3TC+EFV
TDF+3TC+EFV for HIV/HBV co-infection
|
- Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 [ Time Frame: one year ]HIV and HBV viral load decreases in patients taking the regimen
- Incidence of targeted adverse events over 48 weeks [ Time Frame: week 12,24,48 ]Clinical and laboratory safety(liver, renal, hematologic)of TDF+3TC+EFV for HIV/HBV co-infected patients
- CD4+ cell count increase at week 48 [ Time Frame: one year ]CD4+ cell count increases in patients receving the regimen

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751555
China, Beijing | |
National Center for AIDS/STD Control and Prevention, China CDC | |
Beijing, Beijing, China, 102206 |
Principal Investigator: | Fujie ZHANG, MD | National Center for AIDS/STD Control and Prevention, China CDC |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Center for AIDS/STD Control and Prevention, China CDC |
ClinicalTrials.gov Identifier: | NCT01751555 History of Changes |
Other Study ID Numbers: |
co-us-104-0405 |
First Posted: | December 18, 2012 Key Record Dates |
Last Update Posted: | June 28, 2013 |
Last Verified: | December 2010 |
Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
HBV co-infection ART TDF |
Additional relevant MeSH terms:
Coinfection Infection Virus Diseases Parasitic Diseases |