Full Text View
Tabular View
No Study Results Posted
Related Studies
Boosted Atazanavir and Truvada Given Once-Daily - BATON Study
This study has been completed.
First Received: September 20, 2005   Last Updated: April 7, 2008   History of Changes
Sponsor: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00224445
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Truvada
Drug: atazanavir
Drug: ritonavir
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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 PK of Truvada & atazanavir in study subjects receiving Truvada and boosted atazanavir.

Estimated Enrollment: 100
Study Start Date: September 2005
Study Completion Date: January 2007
Detailed Description:

To determine the safety and efficacy (viral load suppression and 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 PK of Truvada and atazanavir in study subjects receiving Truvada and boosted atazanavir.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior antiretroviral treatment.
  • Screening ALT greater than 5 x 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 myelosupressive, 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
    • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224445

Locations
United States, California
Gilead Sciences, Inc.
Foster City, California, United States, 94403
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John Flaherty Gilead Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Gilead Sciences ( John Flaherty, Director, Medical Affairs )
Study ID Numbers: GS-US-164-0115
Study First Received: September 20, 2005
Last Updated: April 7, 2008
ClinicalTrials.gov Identifier: NCT00224445     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Treatment Naive
HIV-1

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Atazanavir
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 30, 2009