Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hiv |
Drug: Regimen:TDF+3TC+EFV |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 [ Time Frame: one year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]CD4+ cell count increases in patients receving the regimen
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: YASONG WU, MD | 86-10-63132151 | yasongwu5@163.com |
| China, Beijing | |
| National Center for AIDS/STD Control and Prevention, China CDC | Recruiting |
| Beijing, Beijing, China, 102206 | |
| Contact: Yasong WU, MD 86-10-63132151 yasongwu5@163.com | |
| Contact: Fujie ZHANG, MD 86-10-63039086 treatment@chinaaids.cn | |
| Principal Investigator: Shaobiao HUANG, MD | |
| Principal Investigator: Xicheng WANG, MD | |
| Principal Investigator: Weiping Cai, MD | |
| Principal Investigator: Lian Yang, MS | |
| Principal Investigator: Hao WU, MD | |
| Sub-Investigator: Tong ZHANG, MD | |
| Principal Investigator: | Fujie ZHANG, MD | National Center for AIDS/STD Control and Prevention, China CDC |
More Information
No publications provided
| 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 |
| Study First Received: | December 14, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
|
HBV co-infection ART TDF |
Additional relevant MeSH terms:
|
Hepatitis B Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Hepatitis Liver Diseases Digestive System Diseases Lamivudine Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013