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

Stopped early · Phase 4

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT00100984

Run by

Hoffmann-La Roche

People needed

8

Starts

2004-07-21

Expected to finish

2005-07-16

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CD4 cell count greater than 50 cells/mm\^3
• HIV-1 RNA viral load greater than or equal to 5000 copies/mL
• Patients must be HIV treatment experienced
• Patients diagnosed with HIV-1 infection

You may not qualify if…

• Female patients must not be able to have children or must be 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

Where it is running

• Study site — Hobson City, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Huntersville, North Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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