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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.
Study NCT00035932   Information provided by Bristol-Myers Squibb
First Received: May 6, 2002   Last Updated: January 8, 2009   History of Changes

May 6, 2002
January 8, 2009
November 2001
January 2003   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00035932 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Correlate the reduction in HIV RNA with baseline phenotype to atazanavir [ Time Frame: Most were measured at 24, 48, and 96 weeks ]
  • Assess changes in CD4 cell counts [ Time Frame: Most were measured at 24, 48, and 96 weeks ]
  • Assess changes in lipid markers [ Time Frame: Most were measured at 24, 48, and 96 weeks ]
  • Assess pharmacokinetic parameters of atazanavir [ Time Frame: Most were measured at 24, 48, and 96 weeks ]
  • Assess certain cardiac effects [ Time Frame: Most were measured at 24, 48, and 96 weeks ]
  • Assess outcome measures such as quality of life and adherence to medications [ Time Frame: Most were measured at 24, 48, and 96 weeks ]
 
Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
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

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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
HIV Infections
  • Drug: Atazanavir + ritonavir + tenofovir + nucleoside
  • Drug: Atazanavir + saquinavir + tenofovir + nucleoside
  • Drug: Lopinavir/ritonavir + tenofovir + nucleoside
  • 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

  • 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

  • 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

 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
358
December 2008
January 2003   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035932
Study Director, Bristol-Myers Squibb
AI424-045
Bristol-Myers Squibb
 
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP