HIVPhase 4BATARNCT00931801
BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.
A Phase 4 study testing atazanavir/raltegravir and atazanavir/tenofovir/emtricitabine in people with HIV, run by Community Research Initiative of New England at 9 sites in United States.
Trial summary
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- atazanavir/raltegravir and atazanavir/tenofovir/emtricitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2009to Mar 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection
- Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
- No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
- Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
- CD4 count>200
- No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
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- Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
- Ability and willingness to provide written informed consent and comply with protocol requirements
Who cannot join
- Prior exposure to raltegravir or elvitegravir
- Women who are pregnant, breast-feeding, or with a positive pregnancy test
- Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
- Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
- Life expectancy less than 6 months
- Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
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- Treatment with proton-pump inhibitor or H2-receptor antagonist
- ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
- Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
- Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Community Research Initiative of New England - Boston
Boston, Massachusetts, 02215
David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group
Dallas, Texas, 75804
Denver Public Health
Denver, Colorado, 80204
AIDS Healthcare Foundation
Los Angeles, California, 90028
Orlando Immunology Center
Orlando, Florida, 32803
Spectrum Medical Group
Phoenix, Arizona, 85012
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Whitman-Walker Clinic
Washington D.C., District of Columbia, 20009
Christi Research
Wichita, Kansas, 67214
About this study
Official title: A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.
- Conditions
- HIV
- Being tested
- atazanavir/raltegravir, atazanavir/tenofovir/emtricitabine
- Keywords
- AIDS, HIV, Atazanavir, Raltegravir, Tenofovir, protease inhibitors
- 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.
atazanavir/raltegravirDrug
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
atazanavir/raltegravirDrug
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
atazanavir/tenofovir/emtricitabineDrug
Also called Truvada
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm No.1 | Experimental | Not described Receives: Drug: atazanavir/raltegravir |
| Intervention Arm No.2 | Experimental | Not described Receives: Drug: atazanavir/raltegravir |
| Control Arm | Active comparator | Continue baseline regimen Receives: Drug: atazanavir/tenofovir/emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Virologic Suppression
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.
Measured: 48 weeks
Secondary outcomes (3)
The Difference in CD4 From Baseline to Week 48
Change in mean CD4 from Baseline to Week 48.
Measured: Baseline and Week 48
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
Measured: Baseline and Week 48
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.
Measured: baseline and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Research Initiative of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Calvin J Cohen, MD, MSc, Principal investigator, Community Research Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931801
- Sponsor's protocol ID
- 09-102
- Acronym
- BATAR
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2009
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine
- ClinicalTrials.gov ID
- NCT00931801
- Acronym / sponsor ID
- BATAR / 09-102
- Conditions
- HIV
- Keywords
- AIDS, HIV, Atazanavir, Raltegravir, Tenofovir, protease inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Community Research Initiative of New EnglandUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Merck Sharp & Dohme LLC
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 11 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm No.1 | Experimental | Drug: atazanavir/raltegravir |
| Intervention Arm No.2 | Experimental | Drug: atazanavir/raltegravir |
| Control Arm | Active comparator | Drug: atazanavir/tenofovir/emtricitabineContinue baseline regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 infection
- Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
- No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
- Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
- CD4 count>200
Key exclusion criteria (12 listed)
- Prior exposure to raltegravir or elvitegravir
- Women who are pregnant, breast-feeding, or with a positive pregnancy test
- Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
- Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
- Life expectancy less than 6 months
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/raltegravirAtazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily | Drug | Intervention Arm No.1 |
| atazanavir/raltegravirAtazanavir 300mg twice daily plus raltegravir 400mg twice daily | Drug | Intervention Arm No.2 |
| atazanavir/tenofovir/emtricitabineAlso: TruvadaContinue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine | Drug | Control Arm |
Primary outcome
Maintenance of Virologic Suppression
Time frame: 48 weeks
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.
3 secondary outcomes
The Difference in CD4 From Baseline to Week 48
Time frame: Baseline and Week 48
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Time frame: Baseline and Week 48
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Time frame: baseline and 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Calvin J Cohen, MD, MSc principal investigator
Community Research Initiative
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atazanavir/raltegravir and atazanavir/tenofovir/emtricitabine in people with HIV, run by Community Research Initiative of New England at 9 sites in United States.
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 9 inclusion and 12 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maintenance of Virologic Suppression (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2017.