A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
|ClinicalTrials.gov Identifier: NCT00135395|
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : February 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Atazanavir+ritonavir Drug: Lopinavir+ritonavir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||February 2006|
|Active Comparator: A||
Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
Other Name: Reyataz
|Active Comparator: B||
Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
- Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12
- Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135395
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|