Trials / Completed
CompletedNCT00234910
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tenofovir DF | TDF 300mg QD for 72 wks |
| DRUG | lopinavir/ritonavir with 2 Nucleoside RTIs | LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2007-06-01
- Completion
- 2008-06-01
- First posted
- 2005-10-10
- Last updated
- 2008-07-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00234910. Inclusion in this directory is not an endorsement.