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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: Atazanavir+ritonavir; Drug: Lopinavir+ritonavir

• Registration Number: NCT00135395
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2008-07
• Disposition First Submitted: 2010-02-03
• Disposition First Submitted QC: 2010-02-03
• Last Update Submitted: 2010-02-03
• Disposition First Posted: 2010-02-05
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients ≥ 18 years of age infected with HIV
• Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
• Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
• The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL)

Exclusion Criteria

• Pregnancy or breastfeeding
• Reported virologic failure to two or more antiretroviral regimens
• Active AIDS-defined opportunistic infection or disease
• Proven or suspected acute hepatitis within 30 days prior to study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Atazanavir+ritonavir	-
B	Lopinavir+ritonavir	-

Primary Outcome Measures

Name	Time	Method
Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Local Institution; 🇵🇷 Santruce, Puerto Rico