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

Roche

Status and phase: Terminated; Phase 4

Conditions: HIV Infection

Treatments: Drug: FUZEON [enfuvirtide]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00100984

ML18021

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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