A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors

Abbott

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Ritonavir; Drug: Lopinavir/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038636

M99-049

Details and patient eligibility

About

The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• HIV positive
• Are at least 18 years old
• Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
• HIV RNA level > 1000 copies/mL
• Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor

Exclusion:

• Subject is pregnant or breast-feeding
• Subject has received an investigational drug within 30 days prior to screening
• Have a history of pancreatitis
• History of intolerance to ritonavir
• Abnormal laboratory tests at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)