Status:
COMPLETED
Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Human Immunodeficiency Virus (HIV) Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.
Eligibility Criteria
Inclusion
- On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks).
- Absence of evidence or suspected virologic failure on antiretroviral therapy
- Absence of known primary mutations in the protease gene
- Only 1 highly active antiretroviral therapy (HAART) prior to current one
- HIV RNA \< 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed)
- On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI + tenofovir \[TDF\]) for at least 8 weeks before study entry, without treatment-limiting adverse effects
Exclusion
- Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
- Active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease)
- Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil Fumarate (TDF) or emtricitabine (FTC).
- CD4 \< 100 cells/mm3
- Grade IV laboratory values: Hemoglobin \< 6.5 g/dL or white blood cells (WBC) \<800/mmm3 or absolute neutrophil count \< 500/mm3, or platelets \< 20,000/mm3 or diffuse petechiae.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00337467
Start Date
June 1 2006
End Date
May 1 2009
Last Update
July 19 2010
Active Locations (7)
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1
Local Institution
Córdoba, Spain, 14004
2
Local Institution
Madrid, Spain, 28007
3
Local Institution
Madrid, Spain, 28034
4
Local Institution
Madrid, Spain, 28040