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Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

This study is ongoing, but not recruiting participants.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00035932
  Purpose

The purpose of this study is to learn how well atazanavir works in combination with ritonavir or saquinavir with tenofovir and a nucleoside to reduce the viral load of treatment experienced subjects with HIV. There is a comparison arm with lopinavir/ritonavir and tenofovir and a nucleoside.


Condition Intervention Phase
HIV Infections
Drug: Atazanavir + ritonavir + tenofovir + nucleoside
Drug: Atazanavir + saquinavir + tenofovir + nucleoside
Drug: Lopinavir/ritonavir + tenofovir + nucleoside
Phase III

MedlinePlus related topics:   AIDS   

Drug Information available for:   Ritonavir    Lopinavir    Atazanavir sulfate    BMS 232632    Tenofovir    Tenofovir disoproxil    Tenofovir Disoproxil Fumarate    Saquinavir    Saquinavir mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Compare the atazanavir treatment regimens to the lopinavir/ritonavir regimen in the reduction of plasma HIV RNA from baseline through 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate the reduction in HIV RNA with baseline phenotype to atazanavir [ Time Frame: Most were measured at 24, 48, and 96 weeks ] [ Designated as safety issue: No ]
  • Assess changes in CD4 cell counts [ Time Frame: Most were measured at 24, 48, and 96 weeks ] [ Designated as safety issue: No ]
  • Assess changes in lipid markers [ Time Frame: Most were measured at 24, 48, and 96 weeks ] [ Designated as safety issue: No ]
  • Assess pharmacokinetic parameters of atazanavir [ Time Frame: Most were measured at 24, 48, and 96 weeks ] [ Designated as safety issue: No ]
  • Assess certain cardiac effects [ Time Frame: Most were measured at 24, 48, and 96 weeks ] [ Designated as safety issue: No ]
  • Assess outcome measures such as quality of life and adherence to medications [ Time Frame: Most were measured at 24, 48, and 96 weeks ] [ Designated as safety issue: No ]

Enrollment:   358
Study Start Date:   November 2001
Estimated Study Completion Date:   December 2008
Primary Completion Date:   January 2003 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
I: Active Comparator

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

Drug: Atazanavir + ritonavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral
II: Active Comparator

ATV 300 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

Drug: Atazanavir + saquinavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral
III: Active Comparator

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

Drug: Lopinavir/ritonavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Virologic failure to two or more HAART regimens that, in total, have included at least one drug from all approved classes (PI, NNRTI, NRTI):

    1. Currently on a failing HAART regimen with two qualifying plasma viral load measurements (hospital/clinic value within 4 weeks of screening with viral load equivalent to =/>1,000c/mL on the Roche Amplicor[TM] and central lab measurements of =/>1,000C.mL (Roche Amplicor[TM]) within 4 weeks of randomization
    2. CD4 cell count =/>50 cells/mm3 obtained within 4 weeks prior to randomization
  • =/> 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate);
  • History of prior virologic response to at least one HAART regimen, defined as a 1.0 log10 decline or a decline in viral load to< 400 C/mL by Roche Amplicor or <500 c/mL by Chiron bDNA
  • Both females of child bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted disease, including HIV. Other contraception in addition to barrier methods is permitted; interaction between atazanavir and oral contraceptives have not been studied.
  • Subjects must be able to provide written informed consent;
  • Subjects should be available for follow-up for a period of at least 48 weeks
  • Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:

    1. serum creatine <1.5 times the upper limit of normal
    2. total serum lipase < 1.4 times the upper limit of normal
    3. liver enzymes (AST, ALT) < 3 times the upper limit of normal
    4. total serum bilirubin < 1.5 times the upper limit of normal

Exclusion Criteria:

  • Prior use (=/>3 days) of atazanavir, TVF or LPV/RTV; if hx of SQV then must be phenotypically sensitive
  • the current failing antiretroviral regimen must have been administered for at least eight weeks at he initiation of screening and must not include both a PI and NNRTI
  • Presence of a newly diagnosed HIV-related opportunistic infection or any medical requiring acute therapy at the time of enrollment
  • Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes (ALT/AST) are <3xULN
  • Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment ot therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4.
  • 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
  • Intractable diarrhea (=/> 6 loose stools/day for at least 7 days consecutive days) within 30 days prior to study entry
  • Pregnancy or breast-feeding
  • History of hemophilia
  • Presence of cardiomyopathy
  • Any one of the following:

    1. QTc interval > 450 msec on the screening EKG
    2. Heart rate < 40 bpm
    3. Pause length > 3 seconds seen on EKG
    4. Clinical symptoms potentially related to heart block
    5. Third degree heart block
  • History of acute or chronic pancreatitis
  • If choosing ddI or d4T as the NRTI: History or signs and symptoms of bilateral peripheral neuropathy =/> Grade 2 at the time of screening
  • Inability to tolerate oral medications
  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035932

Show 29 study locations  Show 29 Study Locations

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Study Director:     Bristol-Myers Squibb     Bristol-Myers Squibb    
  More Information


BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
 
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Bristol-Myers Squibb ( Study Director )
Study ID Numbers:   AI424-045
First Received:   May 6, 2002
Last Updated:   October 22, 2008
ClinicalTrials.gov Identifier:   NCT00035932
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Saquinavir
Acquired Immunodeficiency Syndrome
Atazanavir
Immunologic Deficiency Syndromes
Virus Diseases
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008




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