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
Phase 4
Terminated
- Conditions
- HIV Infection
- Registration Number
- NCT00100984
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method