Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00135395
Start Date
May 1 2004
End Date
February 1 2006
Last Update
February 5 2010
Active Locations (53)
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1
Local Institution
Hobson City, Alabama, United States
2
Local Institution
Montgomery, Alabama, United States
3
Local Institution
Phoenix, Arizona, United States
4
Local Institution
Little Rock, Arkansas, United States