Boosted Atazanavir and Truvada Given Once-Daily - BATON Study
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Sep 2005
Shorter than P25 for phase_4 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJanuary 10, 2013
January 1, 2013
1.3 years
September 20, 2005
January 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Baseline to Week 48
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
Baseline to Week 48
To evaluate steady-state plasma PK of Truvada & atazanavir in study subjects receiving Truvada and boosted atazanavir.
Baseline to Week 48
Study Arms (1)
Truvada + Ritonavir-boosted Atazanavir
EXPERIMENTALAll participants received Truvada plus ritonavir-boosted atazanavir
Interventions
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablet) administered orally once daily (QD)
Atazanavir 300 mg (given as two 150-mg capsules) administered orally QD
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- 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.
You may not qualify if:
- 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.
- 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
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (1)
Gilead Sciences, Inc.
Foster City, California, 94403, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Flaherty
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 23, 2005
Study Start
September 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
January 10, 2013
Record last verified: 2013-01