Status:

TERMINATED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

HIV Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

July 21 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 16 2005

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT00100984

Start Date

July 21 2004

End Date

July 16 2005

Last Update

June 20 2017

Active Locations (20)

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Page 1 of 5 (20 locations)

1

Hobson City, Alabama, United States, 36201

2

Los Angeles, California, United States, 90033

3

Los Angeles, California, United States, 90036

4

Washington D.C., District of Columbia, United States, 20007