HivPhase 4NCT01751555
Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
A Phase 4 study testing Regimen:TDF+3TC+EFV in people with Hiv, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hiv
- What is being tested?
- Regimen:TDF+3TC+EFV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
National Center for AIDS/STD Control and Prevention, China CDC
Beijing, Beijing Municipality, 102206
About this study
Official title: A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection
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.
Read the 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.
- Conditions
- Hiv
- Being tested
- Regimen:TDF+3TC+EFV
- Keywords
- HBV co-infection ART TDF
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regimen:TDF+3TC+EFVDrug
TDF+3TC+EFV for HIV/HBV co-infection
| Study group | Role | What they receive |
|---|---|---|
| TDF/3TC/EFV Treatment HIV/HBV Co-infection | Experimental | TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection Receives: Drug: Regimen:TDF+3TC+EFV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
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
Measured: week 12,24,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Fujie ZHANG, MD, Principal investigator, National Center for AIDS/STD Control and Prevention, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751555
- Sponsor's protocol ID
- co-us-104-0405
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2012
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
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.
PubMed 26831232
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection
- ClinicalTrials.gov ID
- NCT01751555
- Acronym / sponsor ID
- co-us-104-0405
- Conditions
- Hiv
- Keywords
- HBV co-infection ART TDF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- Collaborators
- Gilead Sciences
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDF/3TC/EFV Treatment HIV/HBV Co-infection | Experimental | Drug: Regimen:TDF+3TC+EFVTDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regimen:TDF+3TC+EFVTDF+3TC+EFV for HIV/HBV co-infection | Drug | TDF/3TC/EFV Treatment HIV/HBV Co-infection |
Primary outcome
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
1 secondary outcome
Incidence of targeted adverse events over 48 weeks
Time frame: week 12,24,48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- BackgroundG 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.
- Derived from this study: PubMed 26831232Wu 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fujie ZHANG, MD principal investigator
National Center for AIDS/STD Control and Prevention, China CDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Regimen:TDF+3TC+EFV in people with Hiv, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751555, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.