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BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
This study has been completed.
First Received: January 5, 2006   Last Updated: June 1, 2009   History of Changes
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00272779
  Purpose

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir plus ritonavir versus a combination drug of lopinavir plus ritonavir. A combination drug containing tenofovir and emtricitabine will also be taken by patients in both arms.


Condition Intervention Phase
HIV Infections
Drug: Reyataz + Ritonavir + Truvada
Drug: Kaletra + Truvada
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The proportion of subjects with HIV RNA<50 c/ml [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects with HIV RNA <50 c/ml [ Time Frame: at week 96 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HIV RNA <400 c/ml [ Time Frame: at weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Safety Assessments [ Time Frame: upon occurence ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 882
Study Start Date: November 2005
Study Completion Date: October 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator Drug: Reyataz + Ritonavir + Truvada
Capsules, tablets, Oral, ATV (300mg) + RTV (100mg) + TDF-FTC (300/200mg), once daily, up to 96 Weeks
II: Active Comparator Drug: Kaletra + Truvada

Capsules, tablets, Oral, LPV/RTV (400/100mg) + TDF-FTC (300/200mg), LPV/RTV - twice daily, TDF-FTC - once daily

up to 96 Weeks


  Eligibility

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

Inclusion Criteria:

  • HIV RNA ≥5000 c/ml

Exclusion Criteria:

  • Any antiretroviral therapy within 30 days prior to screening;
  • Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the study;
  • WOCBP using a prohibited contraceptive method
  • WOCBP who are pregnant or breastfeeding;
  • Women with a positive pregnancy test on enrollment or prior to study drug administration;
  • Presence of a newly diagnosed HIV-Related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
  • Suspected primary (acute) HIV infection;
  • Prior antiviral therapy (>30 days of NRTI and/or >7 days of non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within 30 days prior to screening; some exceptions are allowed for ARV therapy in use for Mother-to-child transmission;
  • Subjects with Cushing's syndrome;
  • Untreated hypothyroidism or hyperthyroidism. A patient who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH performed within 30 days of screening is within normal drug range;
  • Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;
  • Subjects with obstructive liver disease;
  • Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
  • Proven or suspected acute hepatitis in the 30 days prior to study entry;
  • Intractable diarrhea (≥6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;
  • Inability to swallow capsules;
  • Active peripheral neuropathy;
  • Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease;
  • Known, clinically significant cardiac conduction system disease.
  • Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:

    1. calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault equation;
    2. total serum lipase ≥ 1.4 times the upper limit of normal;
    3. liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal;
    4. total serum bilirubin ≥ 1.5 times the upper limit of normal.
  • Hypersensitivity to any component of the formulation of study drug;
  • Prohibited therapies;
  • Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements;
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272779

  Show 118 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: AI424-138
Study First Received: January 5, 2006
Last Updated: June 1, 2009
ClinicalTrials.gov Identifier: NCT00272779     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV
Treatment Naive

Study placed in the following topic categories:
Anti-Infective Agents
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Emtricitabine
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

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

ClinicalTrials.gov processed this record on September 01, 2009