| May 6, 2002 |
| November 11, 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
|
| |
| |
| Completed |
| 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):
- 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
- 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:
- serum creatine <1.5 times the upper limit of normal
- total serum lipase < 1.4 times the upper limit of normal
- liver enzymes (AST, ALT) < 3 times the upper limit of normal
- total serum bilirubin < 1.5 times the upper limit of normal
Exclusion Criteria:
|
| 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 |
| November 2009 |