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| 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 |
| 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 |
| 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
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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
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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 |
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):
Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:
Exclusion Criteria:
Any one of the following:
Contacts and Locations![]() |
Show 29 Study Locations |
| Bristol-Myers Squibb |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 
  |
| 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 |
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