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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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Immunodeficiency Virus (HIV) Infections

Intervention: Atazanavir + Ritonavir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

Official title: Phase IIIb Multicenter, Single Arm, Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Maintenance With Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in HIV-Infected Patients Evidencing Virologic Suppression OREY (Only REYataz) Study

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Treatment Failure Through Week 48

Secondary outcome:

Percentage of Participants With Treatment Failure Through Week 96

Percentage of Participants With Virological Rebound Through Week 48

Percentage of Participants With Virological Rebound Through Week 96

Cumulative Proportion of Participants Without Treatment Failure Through Week 100

Proportion of Participants With Virologic Rebound Through Week 96

Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24

Mean Change From Baseline in CD4 Cell Count at Week 48

Mean Change From Baseline in CD4 Cell Count at Week 96

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs

Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48

Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96

Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48

Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Local Institution, Cordoba 14004, Spain

Local Institution, Madrid 28007, Spain

Local Institution, Madrid 28034, Spain

Local Institution, Madrid 28040, Spain

Local Institution, Madrid 28041, Spain

Local Institution, Madrid 28046, Spain

Local Institution, Malaga 29010, Spain

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2006
Last updated: June 18, 2010

Page last updated: August 23, 2015

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