A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen

NCT00135395 | Completed Phase 3

• 1 other identifier: AI424-103
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 53

Brief Summary

The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

Conditions

HIV Infections

Keywords

HIV/AIDS; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12

Secondary Outcomes (1)

• Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Atazanavir+ritonavir

B

ACTIVE COMPARATOR

Drug: Lopinavir+ritonavir

Interventions

Atazanavir+ritonavir DRUG

Capsules, Oral, 300mg/100mg, once daily, 24 weeks.

Also known as: Reyataz

A

Lopinavir+ritonavir DRUG

Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age infected with HIV
• Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
• Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
• The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA \< 400 c/mL)

You may not qualify if:

• Pregnancy or breastfeeding
• Reported virologic failure to two or more antiretroviral regimens
• Active AIDS-defined opportunistic infection or disease
• Proven or suspected acute hepatitis within 30 days prior to study entry

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (53)

Local Institution

Hobson City, Alabama, United States

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Montgomery, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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San Mateo, California, United States

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Tarzana, California, United States

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West Hollywood, California, United States

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Norwalk, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Atlantis, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Safety Harbor, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Berkley, Michigan, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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East Orange, New Jersey, United States

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Hillsborough, New Jersey, United States

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Jersey City, New Jersey, United States

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Brooklyn, New York, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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Valhalla, New York, United States

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Greenville, North Carolina, United States

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Huntersville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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Hampton, Virginia, United States

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Santruce, Puerto Rico

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MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

atazanavir, ritonavir drug combination; Atazanavir Sulfate; Lopinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Pyrimidinones; Pyrimidines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 26, 2005
• Study Start: May 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: February 5, 2010

Record last verified: 2008-07

Locations

US (52); PR (1)