Clinical Trials Directory

Trials / Completed

CompletedNCT00004581

A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
300 (planned)
Sponsor
Abbott · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Detailed description

Patients receive 1 of the following: 1. ABT-378/RTV plus NVP plus 2 NRTIs; or 2. Investigator-selected PI(s) plus NVP plus 2 NRTIs.

Conditions

Interventions

TypeNameDescription
DRUGLopinavir/Ritonavir
DRUGNevirapine

Timeline

First posted
2001-08-31
Last updated
2009-02-20

Locations

88 sites across 14 countries: United States, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Poland, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom

Source: ClinicalTrials.gov record NCT00004581. Inclusion in this directory is not an endorsement.