HIV InfectionsPhase 4NCT00224445
Boosted Atazanavir and Truvada Given Once-Daily - BATON Study
A Phase 4 study testing Truvada, Atazanavir and Ritonavir in people with HIV Infections, run by Gilead Sciences at 1 site in United States.
Trial summary
To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir boosted with ritonavir in treatment naive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Truvada, Atazanavir and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jan 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (greater than or equal to 18 years) male or non-pregnant female HIV 1- infected subjects regardless of race or ethnicity.
- Antiretroviral treatment-naïve.
- Plasma HIV 1 RNA greater than 1000 copies/mL (Roche Amplicor HIV 1 Monitor Test Version 1.5 Ultrasensitive method, with a reflex to Standard for results greater than 75,000 and dilution for results greater than 750,000). There are no CD4 criteria for study inclusion.
- Adequate renal function defined as a calculated creatinine clearance (CLCr) greater than or equal to 50 mL/min according to the Cockcroft-Gault formula:
- Male: (140 - age in years) x (wt in kg) divided by 72 x (serum creatinine in mg/dL) = CLCr (mL/min.
- Female: (140 - age in years) x (wt in kg) divided by 72 x (serum creatinine in mg/dL) x 0.85 = CLCr (mL/min).
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- Negative serum pregnancy test (females of childbearing potential only).
- Males and females (of childbearing potential, i.e. less than 2 years post-menopausal) must agree to avoid pregnancy by sexual abstinence, or utilization of a highly effective method of birth control throughout the study period and for 30 days following discontinuation of study drug.
- Life expectancy greater than or equal to 1 year.
- Subjects should be available for follow up for a period of at least 48 weeks.
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
Who cannot join
- Prior antiretroviral treatment.
- Screening ALT greater than 5 x the upper limit of the normal range (ULN).
- Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver transaminases (ALT) are less than 5 x ULN.
- A new AIDS defining condition diagnosed (with the exception of CD4 criteria) within 30 days of baseline.
- Previous therapy with agents with systemic myelosuppressive, pancreatoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
- Presence of cardiomyopathy.
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- Heart rate less than 40 bpm.
- Clinical symptoms potentially related to heart block (syncope, palpitations, unexplained dizziness)
- Known conduction disease.
- Third degree heart block.
- Clinically significant laboratory values that would preclude prescribing antiretroviral therapy, in the opinion of the investigator.
- Receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period):
- Nephrotoxic agents (aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, other agents with significant nephrotoxic potential):
- Adefovir dipivoxil
- Probenecid
- Systemic chemotherapeutic agents (i.e., cancer treatment medications)
- Systemic corticosteroids
- Interleukin 2 (IL 2)
- Investigational agents (except upon approval by Gilead).
- Drugs that are contraindicated with atazanavir and/or ritonavir including:
- midazolam
- triazolam
- ergot alkaloids
- pimozide
- proton-pump inhibitors
- H2 blockers
- lovastatin
- simvastatin
- diltiazem
- amiodarone
- bepridil
- flecainide
- propafenone
- quinidine
- St. John's Wort
- rifampin
- irinotecan
- Pregnant or lactating subjects.
- Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
- Current alcohol or substance abuse judged by the investigator to potentially interfere with subject adherence.
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study.
- Active, serious infections (other than HIV 1 infection) requiring parenteral antimicrobial therapy within 15 days prior to screening.
- Prior history of significant renal or bone disease.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
- Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g., infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gilead Sciences, Inc.
Foster City, California, 94403
About this study
Official title: Boosted Atazanavir and Truvada Given Once-Daily (BATON Study): A Phase 4 Study of Safety, Efficacy & Adherence in HIV Infected, Antiretroviral Naïve Subjects Treated With a Simple Once-Daily Regimen
To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir boosted with ritonavir in treatment naive patients.
Read the detailed description
To determine the safety and efficacy (viral load suppression and cluster of differentiation 4 [CD4] changes) of a simple, once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with the protease inhibitor atazanavir (ATV) boosted with ritonavir (ATV/r).
To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir.
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
To evaluate steady-state plasma pharmacokinetics (PK) of Truvada and atazanavir in study subjects receiving Truvada and boosted atazanavir.
- Conditions
- HIV Infections
- Being tested
- Truvada, Atazanavir, Ritonavir
- Keywords
- Treatment Naive, HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablet) administered orally once daily (QD)
AtazanavirDrug
Atazanavir 300 mg (given as two 150-mg capsules) administered orally QD
RitonavirDrug
Ritonavir 100 mg capsule administered orally QD
| Study group | Role | What they receive |
|---|---|---|
| Truvada + Ritonavir-boosted Atazanavir | Experimental | All participants received Truvada plus ritonavir-boosted atazanavir Receives: Drug: Truvada; Drug: Atazanavir; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety/efficacy (viral load suppression and CD4 changes) of a once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada.
Measured: Baseline to Week 48
Secondary outcomes (3)
To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir.
Measured: Baseline to Week 48
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
Measured: Baseline to Week 48
To evaluate steady-state plasma PK of Truvada & atazanavir in study subjects receiving Truvada and boosted atazanavir.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Flaherty, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224445
- Sponsor's protocol ID
- GS-US-164-0115
- Status last verified
- Jan 2013
- First submitted
- 20 Sep 2005
- Last updated
- 10 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosted Atazanavir and Truvada Given Once-Daily (BATON Study): A Phase 4 Study of Safety, Efficacy & Adherence in HIV Infected, Antiretroviral Naïve Subjects Treated With a Simple Once-Daily Regimen
- ClinicalTrials.gov ID
- NCT00224445
- Acronym / sponsor ID
- GS-US-164-0115
- Conditions
- HIV Infections
- Keywords
- Treatment Naive, HIV-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 23 Sep 2005 (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.
To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir boosted with ritonavir in treatment naive patients.
Detailed description
To determine the safety and efficacy (viral load suppression and cluster of differentiation 4 [CD4] changes) of a simple, once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with the protease inhibitor atazanavir (ATV) boosted with ritonavir (ATV/r).
To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir.
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
To evaluate steady-state plasma pharmacokinetics (PK) of Truvada and atazanavir in study subjects receiving Truvada and boosted atazanavir.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Truvada + Ritonavir-boosted Atazanavir | Experimental | Drug: Truvada, Drug: Atazanavir, Drug: RitonavirAll participants received Truvada plus ritonavir-boosted atazanavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult (greater than or equal to 18 years) male or non-pregnant female HIV 1- infected subjects regardless of race or ethnicity.
- Antiretroviral treatment-naïve.
- Plasma HIV 1 RNA greater than 1000 copies/mL (Roche Amplicor HIV 1 Monitor Test Version 1.5 Ultrasensitive method, with a reflex to Standard for results greater than 75,000 and dilution for results greater than 750,000). There are no CD4 criteria for study inclusion.
- Adequate renal function defined as a calculated creatinine clearance (CLCr) greater than or equal to 50 mL/min according to the Cockcroft-Gault formula:
- Male: (140 - age in years) x (wt in kg) divided by 72 x (serum creatinine in mg/dL) = CLCr (mL/min.
Key exclusion criteria (45 listed)
- Prior antiretroviral treatment.
- Screening ALT greater than 5 x the upper limit of the normal range (ULN).
- Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver transaminases (ALT) are less than 5 x ULN.
- A new AIDS defining condition diagnosed (with the exception of CD4 criteria) within 30 days of baseline.
- Previous therapy with agents with systemic myelosuppressive, pancreatoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
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 |
|---|---|---|
| TruvadaTruvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablet) administered orally once daily (QD) | Drug | Truvada + Ritonavir-boosted Atazanavir |
| AtazanavirAtazanavir 300 mg (given as two 150-mg capsules) administered orally QD | Drug | Truvada + Ritonavir-boosted Atazanavir |
| RitonavirRitonavir 100 mg capsule administered orally QD | Drug | Truvada + Ritonavir-boosted Atazanavir |
Primary outcome
Determine the safety/efficacy (viral load suppression and CD4 changes) of a once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada.
Time frame: Baseline to Week 48
3 secondary outcomes
To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir.
Time frame: Baseline to Week 48
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
Time frame: Baseline to Week 48
To evaluate steady-state plasma PK of Truvada & atazanavir in study subjects receiving Truvada and boosted atazanavir.
Time frame: Baseline to Week 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 10 Jan 2013.
- Gilead WebsiteLink provided by the sponsor.
- Truvada WebsiteLink provided by the sponsor.
- Study ResultsLink provided by the sponsor.
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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.
John Flaherty study director
Gilead Sciences
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 Truvada, Atazanavir and Ritonavir in people with HIV Infections, run by Gilead Sciences at 1 site 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 11 inclusion and 45 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 10 Jan 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 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?
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?
Determine the safety/efficacy (viral load suppression and CD4 changes) of a once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada. (time frame: Baseline to Week 48). 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 10 Jan 2013.