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A 48 week study comparing treatment with saquinavir + lopinavir/ritonavir in combination with enfuvirtide HAART versus saquinavir + lopinavir/ritonavir + other nucleoside combinations to see the efficacy of these treatments in patients infected with HIV-1 - Article


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Nucleoside Analogues

 




Clinical Trial: A 48 week study comparing treatment with saquinavir + lopinavir/ritonavir in combination with enfuvirtide HAART versus saquinavir + lopinavir/ritonavir + other nucleoside combinations to see the efficacy of these treatments in patients infected with HIV-1

This study is currently recruiting patients.

Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche

Purpose

The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.

Condition Treatment or Intervention Phase
HIV
 Drug: enfuvirtide
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • CD4 cell count > 50 cells/mm3
  • HIV - 1 RNA viral load >/= 5000 copies/mL
  • Patients must be HIV treatment experienced
  • Patients diagnosed with HIV - 1 infection

Exclusion Criteria:

  • Female patients must not be able to have children or under effective contraceptives
  • Female patients who are pregnant
  • have taken enfuvirtide and/or T-1249 before
  • have serious kidney problems
  • alcohol and/or drug abuse
  • have had an organ transplant

Location and Contact Information

Please reference Study ID Number: RLI-ML18021      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Hobson City,  Alabama,  36201,  United States; Recruiting

California
      Los Angeles,  California,  90069,  United States; Recruiting

      Los Angeles,  California,  90033,  United States; Not yet recruiting

District of Columbia
      Washington,  District of Columbia,  20009,  United States; Recruiting

      Washington,  District of Columbia,  20007,  United States; Recruiting

Florida
      Altamonte Springs,  Florida,  32701,  United States; Recruiting

Georgia
      Atlanta,  Georgia,  30308,  United States; Recruiting

      Macon,  Georgia,  31201,  United States; Recruiting

Illinois
      Chicago,  Illinois,  60657,  United States; Recruiting

      Chicago,  Illinois,  80612,  United States; Recruiting

Maryland
      Baltimore,  Maryland,  21201,  United States; Recruiting

Massachusetts
      Boston,  Massachusetts,  02215,  United States; Recruiting

Mississippi
      Jackson,  Mississippi,  39216,  United States; Recruiting

Missouri
      St. Louis,  Missouri,  63139,  United States; Recruiting

New Jersey
      Newark,  New Jersey,  07103,  United States; Recruiting

New York
      New York,  New York,  10011,  United States; Recruiting

      New York,  New York,  10016,  United States; Recruiting

North Carolina
      Huntersville,  North Carolina,  28078,  United States; Recruiting

Texas
      Houston,  Texas,  77004,  United States; Recruiting

      Dallas,  Texas,  75246,  United States; Recruiting

More Information

Study ID Numbers:  ML18021
Record last reviewed:  April 2005
Last Updated:  April 6, 2005
Record first received:  January 7, 2005
ClinicalTrials.gov Identifier:  NCT00100984
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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November 30, 2009



Page Updated: January 17, 2009
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