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Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00096746
First received: November 15, 2004
Last updated: April 12, 2011
Last verified: April 2011
History of Changes
  Purpose

This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.


Condition Intervention
HIV Infection
 Drug: LPV/RTV + 2NRTIs

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The log10 HIV RNA change from baseline for each cohort. [ Time Frame: through Week 48 ]

Secondary Outcome Measures:
  • Evaluate proportion of patients with plasma HIV RNA <50 copies/mL [ Time Frame: at Weeks 24, 48, 72, and 96. ]

Estimated Enrollment: 200
Study Start Date: November 2004
Estimated Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A1
HIV infected individuals on first line ATV based HAART with presence of I50L mutation.
 Drug: LPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.
A2
HIV infected PI naïve on failed NNRTI based regimen.
 Drug: LPV/RTV + 2NRTIs
Tablets, Oral, Variable, Twice daily, 48 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV infected individuals on first line ATV based HAART with presence of I50L mutation & HIV infected PI naïve on failed NNRTI based regimen.

Criteria

Inclusion Criteria:

  • Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound

Exclusion Criteria:

  • Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
  • Women who are pregnant or breastfeeding.
  • A life expectancy of <12 months.
  • Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
  • Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096746

  Hide Study Locations
Locations
United States, Arizona
Local Institution
Phoenix, Arizona, United States
United States, Florida
Local Institution
altamonte Springs, Florida, United States
Local Institution
Ft. Lauderdale, Florida, United States
Local Institution
Vero Beach, Florida, United States
United States, Hawaii
Local Institution
Honolulu, Hawaii, United States
United States, Kansas
Local Instution
Wichita, Kansas, United States
United States, Kentucky
Local Instution
Lexington, Kentucky, United States
Local Institution
Louisville, Kentucky, United States
United States, New Jersey
Local Institution
East Orange, New Jersey, United States
United States, New York
Local Institution
Albany, New York, United States
United States, North Carolina
Local Institution
Huntersville, North Carolina, United States
United States, Oregon
Local Institution
Portland, Oregon, United States
United States, Texas
Local Institution
Dallas, Texas, United States
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
La Plata, Buenos Aires, Argentina
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Mar Del Plata, Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
Local Institution
Buenos Aires, Argentina
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Cordoba, Argentina
Brazil
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Curitiba, Parana, Brazil
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Recife, Pernambuco, Brazil
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Campinas, Sao Paulo, Brazil
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Rio De Janeiro, Brazil
Local Institution
Sao Paulo, Brazil
Guatemala
Local Institution
Guatemala, Guatemala
Mexico
Local Institution
Guadalajara, Jalisco, Mexico
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Durango, Mexico
Peru
Local Institution
Lima, Peru
South Africa
Local Institution
Port Elizabeth, Eastern Cape, South Africa
Local Institution
Bloemfontein, Free State, South Africa
Local Institution
Bedford Gardens, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
Local Institution
Meadowdale, Gauteng, South Africa
Local Institution
Westdene, Gauteng, South Africa
Local Institution
Mowbray, Western Cape, South Africa
Local Institution
Rugby, Western Cape, South Africa
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Chair: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00096746     History of Changes
Other Study ID Numbers: AI424-079
Study First Received: November 15, 2004
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013