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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus (HIV) Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Group Type EXPERIMENTAL

Atazanavir + Ritonavir

Intervention Type DRUG

Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks

Interventions

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Atazanavir + Ritonavir

Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks

Intervention Type DRUG

Other Intervention Names

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Reyataz BMS-232632

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No