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

April 12, 2011 updated by: Bristol-Myers Squibb

An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The log10 HIV RNA change from baseline for each cohort.
Time Frame: through Week 48
through Week 48

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Chair: Bristol-Myers Squibb, Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

November 15, 2004

First Submitted That Met QC Criteria

November 15, 2004

First Posted (Estimate)

November 16, 2004

Study Record Updates

Last Update Posted (Estimate)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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