HIV InfectionPhase 3NCT00280969
Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment
A Phase 3 study testing atazanavir arm and efavirenz in people with HIV Infection, run by International Medical Center of Japan at 1 site in Japan.
Trial summary
A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- HIV Infection
- What is being tested?
- atazanavir arm and efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2005to Sep 2009
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- serological diagnosis of HIV infection
- male aged over 20 years old
- CD4 at enrollment between 100 to 300
- body weight over 40kg
- enable to obtain the written informed consent
Who cannot join
- Patients who are considered unable to complete 48 weeks of study by their physician.
- Patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems.
- Patients who have the history of hypersensitivity with lamivudine.
- Hepatitis B carrier.
- Blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils less than 1000/mm3, serum total bilirubin more than 2.0mg/dl, GOT/GPT/LDH more than two times of upper normal limit, serum creatinine more than 1.2mg/dl.
- Patients who have had radiation or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study .
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- Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteroid is the exception.
- Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition.
- Patients with AIDS defining illness.
- Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study.
- Patients with acute retroviral syndrome.
- Patients with psychiatric disorder.
- Patients whose physician consider the study enrollment inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz
A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)
Read the detailed description
A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)
The primary endpoint is antiretroviral effect at the 48th week.
The secondary endpoint is;1. Evaluation of immunological effect and safety in 48 weeks. 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.
- Conditions
- HIV Infection
- Being tested
- atazanavir arm, efavirenz
- Keywords
- HIV infection, treatment, efavirenz, atazanavir, ritonavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atazanavir armDrug
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
efavirenzDrug
Patients are treated with efavirenz 300mg along with Epzicom.
| Study group | Role | What they receive |
|---|---|---|
| atazanavir arm | Experimental | Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom. Receives: Drug: atazanavir arm |
| efavirenz arm | Active comparator | Patients are treated with efavirenz 300mg along with Epzicom. Receives: Drug: efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral effect at the 48th week
Measured: 48 weeks
Secondary outcomes (2)
1. Evaluation of immunological effect and safety in 48 weeks.
Measured: 48 weeks
2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2009
- Study completionSep 2009
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 InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 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, M.D., phD., Study chair, International Medical Center of Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280969
- Sponsor's protocol ID
- QD001
- Status last verified
- Mar 2015
- First submitted
- 22 Jan 2006
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Honda M, Ishisaka M, Ishizuka N, Kimura S, Oka S; Japanese Anti-HIV-1 QD Therapy Study Group. Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine. Intern Med. 2011;50(7):699-705. doi: 10.2169/internalmedicine.50.4572. Epub 2011 Apr 1.
PubMed 21467701
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
- Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz
- ClinicalTrials.gov ID
- NCT00280969
- Acronym / sponsor ID
- QD001
- Conditions
- HIV Infection
- Keywords
- HIV infection, treatment, efavirenz, atazanavir, ritonavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- International Medical Center of JapanOther government
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Jan 2006 (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 selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)
Detailed description
A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)
The primary endpoint is antiretroviral effect at the 48th week.
The secondary endpoint is;1. Evaluation of immunological effect and safety in 48 weeks. 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atazanavir arm | Experimental | Drug: atazanavir armPatients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom. |
| efavirenz arm | Active comparator | Drug: efavirenzPatients are treated with efavirenz 300mg along with Epzicom. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- serological diagnosis of HIV infection
- male aged over 20 years old
- CD4 at enrollment between 100 to 300
- body weight over 40kg
- enable to obtain the written informed consent
Key exclusion criteria (13 listed)
- Patients who are considered unable to complete 48 weeks of study by their physician.
- Patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems.
- Patients who have the history of hypersensitivity with lamivudine.
- Hepatitis B carrier.
- Blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils less than 1000/mm3, serum total bilirubin more than 2.0mg/dl, GOT/GPT/LDH more than two times of upper normal limit, serum creatinine more than 1.2mg/dl.
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 |
|---|---|---|
| atazanavir armPatients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom. | Drug | atazanavir arm |
| efavirenzPatients are treated with efavirenz 300mg along with Epzicom. | Drug | efavirenz arm |
Primary outcome
Antiretroviral effect at the 48th week
Time frame: 48 weeks
2 secondary outcomes
1. Evaluation of immunological effect and safety in 48 weeks.
Time frame: 48 weeks
2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.
Time frame: 96 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 21467701Honda M, Ishisaka M, Ishizuka N, Kimura S, Oka S; Japanese Anti-HIV-1 QD Therapy Study Group. Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine. Intern Med. 2011;50(7):699-705. doi: 10.2169/internalmedicine.50.4572. Epub 2011 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, M.D., phD. 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 3 study testing atazanavir arm and efavirenz in people with HIV Infection, 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 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 at the 48th week (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 NCT00280969, 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.