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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038636

Enrollment

Registered

2002-06-04

Start date

2000-09-30

Completion date

Unknown

Last updated

2006-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV

Brief summary

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

Interventions

DRUGLopinavir/ritonavir

DRUGRitonavir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts	—

Countries

France, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026