Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

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Detailed Description

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Conditions

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HIV-Associated Lipodystrophy Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group Type ACTIVE_COMPARATOR

Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)

Intervention Type DRUG

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

Control Arm

Group Type ACTIVE_COMPARATOR

continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

Intervention Type DRUG

Protease inhibitor \[PI\] combination + 2 NRTIs

Interventions

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Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)

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

Intervention Type DRUG

continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

Protease inhibitor \[PI\] combination + 2 NRTIs

Intervention Type DRUG

Other Intervention Names

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Reyataz

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks prior to screening. Subjects may not have experienced virological failure to more than one prior PI-containing regimen. Must be able to swallow tablets
* Viral load \<400 c/mL at screening and stable for at least 6 months
* Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio \>0.90 and Waist Circumference \>88.2 cm for men and Waist Circumference \>75.3 for women

Exclusion Criteria

* Pregnant or breastfeeding women
* New HIV-related opportunistic infections
* Active alcohol or substance use
* Grade 4 lab toxicity
* History of taking atazanavir (ATV)
* Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors (NNRTI)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No