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Research Studies:
150L SUBSTITUTION

A Study To Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure On a HAART Regimen Containing Atazanavir

Purpose:

You are eligible to participate in this research study if you have failed a regimen containing ATV (Atazanavir), a protease inhibitor. Mutations in the virus which cause resistance to one anti-HIV drug often cause resistance to other drugs in the same class. A large amount of research, however, has indicated that ATV may force the virus to bear a very special mutation, called the "I50L substitution." Virus bearing this mutation will be resistant to ATV, but responds better to other protease inhibitors (PIs) in the test tube than virus without this mutation. The purpose of this study is to find out the pattern of resistance, including the I50L substitution, when subjects failed an ATV (Atazanavir) containing regimen.

Eligibility
Criteria:

  • Currently on an antiretroviral regimen containing ATV with either:

    1. a confirmed virologic rebound (an HIV RNA > 1000 copies/mL, after achieving a value < 400 copies/mL on at least two consecutive measurements), OR
    2. HIV RNA > 1000 copies/mL after 24 weeks of therapy.
  • In both cases, HIV RNA > 1000 copies/mL must be confirmed by screening/enrollment measurement within 14-90 days of the first HIV RNA value.

  • The subject must be on the ATV-containing HAART regimen at the time of enrollment.

Study
Requirements:

You will be asked to come in for a single study visit.

Benefits:

You will receive up to $20.00 for participation in this study to cover your costs, such as meals, transportation, and parking.

Study
Personnel:

Christine A. Wanke, MD Principal Investigator

Contact:

(617) 636- 0921

CURRENTLY ENROLLING

Privacy and confidentiality are strictly maintained.

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Research:
United States >
   150L SUB | BIENESTAR | CARE | CARE II | CYTOCHROME | DIETFRAM 2
   HALO | KALETRA | LIPID | PERTH | SWITCH | TH9507 | TH9507-CTR-1011
 
International >
   India | Kenya | Pakistan

Nutrition/Infection Unit | Research | HIV Resources | TNC - CDAAR | NAA


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Version date: July 01, 2009
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