HIV InfectionsPhase 4NCT00544128
Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
A Phase 4 study testing lamivudine, abacavir , ritonavir, atazanavir and emtricitabine, tenofovir, ritonavir, atazanavir in people with HIV Infections, run by International Medical Center of Japan at 1 site in Japan.
Trial summary
A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- lamivudine, abacavir , ritonavir, atazanavir and emtricitabine, tenofovir, ritonavir, atazanavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2007to Feb 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of HIV infection,
- Antiretroviral initiation is recommended by current clinical guidelines,
- Treatment naïve,
- Age over 20 years old Japanese,
- Able to obtain written informed consent
Who cannot join
- Current malabsorption condition,
- Prior use of lamivudine for hepatitis B treatment,
- Positive serology of Hepatitis B surface antigen,
- Patients who have following abnormal laboratory results within 6 weeks prior enrollment;
- alanine aminotransferase is more than 2.5 times higher of upper normal limit
- estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
Show all 11Show fewer
- serum phosphate level is less than 2.0mg/dl
- Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
- Patients in pregnancy or breat feeding
- Patients who are taking medications contraindicated combine use of study medicine
- Patients whose primary care physicians consider inadequate to be enroll the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study)
A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.
Read the detailed description
In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.
The primary endpoint is the antiretroviral effect over 48 weeks.
The secondary endpoints are;
- The immunologic effects from baseline at the 48th and 144th week
- Reasons of treatment failure by 144th week
- Adverse events and their rate of incidence by 144th week
- Serum concentration of tenofovir in selected patients
- Serum concentration of atazanavir in selected patients
- Renal complication in tenofovir arm
- Conditions
- HIV Infections
- Being tested
- lamivudine, abacavir , ritonavir, atazanavir, emtricitabine, tenofovir, ritonavir, atazanavir
- Keywords
- HIV, initial therapy, once daily, randomized trial, non inferiority, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamivudine, abacavir , ritonavir, atazanavirDrug
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
emtricitabine, tenofovir, ritonavir, atazanavirDrug
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.
| Study group | Role | What they receive |
|---|---|---|
| Epzicom Arm | Active comparator | Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg Receives: Drug: lamivudine, abacavir , ritonavir, atazanavir |
| Truvada Arm | Active comparator | Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg Receives: Drug: emtricitabine, tenofovir, ritonavir, atazanavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
antiretroviral effect over 48 weeks
Measured: 48 weeks
Secondary outcomes (3)
The immunologic effects from baseline at the 48th and 144th week
Measured: 144 weeks
Reasons of treatment failure by 144th week
Measured: 144 weeks
Adverse events and their rate of incidence by 144th week
Measured: 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Medical Center of Japan
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Principal investigator, Shinichi Oka, M.D., International Medical Center of Japan
- Investigators
- Shinichi Oka, MD, Study chair, International Medical Center of Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544128
- Sponsor's protocol ID
- IMCJ-H19-466
- Other IDs
- ET001
- Status last verified
- Mar 2015
- First submitted
- 12 Oct 2007
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nishijima T, Takano M, Ishisaka M, Komatsu H, Gatanaga H, Kikuchi Y, Endo T, Horiba M, Kaneda S, Uchiumi H, Koibuchi T, Naito T, Yoshida M, Tachikawa N, Ueda M, Yokomaku Y, Fujii T, Higasa S, Takada K, Yamamoto M, Matsushita S, Tateyama M, Tanabe Y, Mitsuya H, Oka S; Epzicom-Truvada study team. Abacavir/lamivudine versus tenofovir/emtricitabine with atazanavir/ritonavir for treatment-naive Japanese patients with HIV-1 infection: a randomized multicenter trial. Intern Med. 2013;52(7):735-44. doi: 10.2169/internalmedicine.52.9155. Epub 2013 Apr 1.
PubMed 23545667
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study)
- ClinicalTrials.gov ID
- NCT00544128
- Acronym / sponsor ID
- IMCJ-H19-466
- Conditions
- HIV Infections
- Keywords
- HIV, initial therapy, once daily, randomized trial, non inferiority, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- International Medical Center of JapanOther government
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Oct 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Oct 2007 (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.
A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.
Detailed description
In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.
The primary endpoint is the antiretroviral effect over 48 weeks.
The secondary endpoints are;
- The immunologic effects from baseline at the 48th and 144th week
- Reasons of treatment failure by 144th week
- Adverse events and their rate of incidence by 144th week
- Serum concentration of tenofovir in selected patients
- Serum concentration of atazanavir in selected patients
- Renal complication in tenofovir arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epzicom Arm | Active comparator | Drug: lamivudine, abacavir , ritonavir, atazanavirPatients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg |
| Truvada Arm | Active comparator | Drug: emtricitabine, tenofovir, ritonavir, atazanavirPatients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of HIV infection,
- Antiretroviral initiation is recommended by current clinical guidelines,
- Treatment naïve,
- Age over 20 years old Japanese,
- Able to obtain written informed consent
Key exclusion criteria (11 listed)
- Current malabsorption condition,
- Prior use of lamivudine for hepatitis B treatment,
- Positive serology of Hepatitis B surface antigen,
- Patients who have following abnormal laboratory results within 6 weeks prior enrollment;
- Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
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 |
|---|---|---|
| lamivudine, abacavir , ritonavir, atazanavirPatients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg | Drug | Epzicom Arm |
| emtricitabine, tenofovir, ritonavir, atazanavirPatients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg. | Drug | Truvada Arm |
Primary outcome
antiretroviral effect over 48 weeks
Time frame: 48 weeks
3 secondary outcomes
The immunologic effects from baseline at the 48th and 144th week
Time frame: 144 weeks
Reasons of treatment failure by 144th week
Time frame: 144 weeks
Adverse events and their rate of incidence by 144th week
Time frame: 144 weeks
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 30 Mar 2015.
- Results publication: PubMed 23545667Nishijima T, Takano M, Ishisaka M, Komatsu H, Gatanaga H, Kikuchi Y, Endo T, Horiba M, Kaneda S, Uchiumi H, Koibuchi T, Naito T, Yoshida M, Tachikawa N, Ueda M, Yokomaku Y, Fujii T, Higasa S, Takada K, Yamamoto M, Matsushita S, Tateyama M, Tanabe Y, Mitsuya H, Oka S; Epzicom-Truvada study team. Abacavir/lamivudine versus tenofovir/emtricitabine with atazanavir/ritonavir for treatment-naive Japanese patients with HIV-1 infection: a randomized multicenter trial. Intern Med. 2013;52(7):735-44. doi: 10.2169/internalmedicine.52.9155. Epub 2013 Apr 1.
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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.
Shinichi Oka, MD study chair
International Medical Center of Japan
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 lamivudine, abacavir , ritonavir, atazanavir and emtricitabine, tenofovir, ritonavir, atazanavir in people with HIV Infections, run by International Medical Center of Japan at 1 site in Japan.
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 5 inclusion and 11 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 30 Mar 2015. 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 Japan. 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?
antiretroviral effect over 48 weeks (time frame: 48 weeks). 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 NCT00544128, which also lists 1 linked publication.
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 30 Mar 2015.