Boosted Atazanavir and Truvada Given Once-Daily - BATON Study

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00224445

Run by

Gilead Sciences

People needed

100

Starts

2005-09-01

Expected to finish

2007-01-01

Last updated by the study team

2013-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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).
• 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
• 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

Where it is running

• Gilead Sciences, Inc. — Foster City, California, United States

Full record on ClinicalTrials.gov

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