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 (OREY)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 3

Conditions

Human Immunodeficiency Virus (HIV) Infections

Treatments

Drug: Atazanavir + Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00337467
AI424-227

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

A1
Experimental group
Treatment:
Drug: Atazanavir + Ritonavir

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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