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

• Status: Terminated
• Trial end date: 2005-07-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Enfuvirtide; Lopinavir; Saquinavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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