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

NCT ID: NCT00038636

Last Updated: 2006-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lopinavir/ritonavir

Intervention Type DRUG

Ritonavir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eugene Sun, M.D.

Role: STUDY_CHAIR

Divisional Vice President, Infectious Diseases and Virology Dept.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCSD Treatment Center

San Diego, California, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Hopital Pitie-Salpetriere

Paris, , France

Site Status

Hospital Europeen Georges Pompidou

Paris, , France

Site Status

Hospital Clinico de Barcelona

Barcelona, , Spain

Site Status

Ciutat Sanitaria de Bellvitge

Barcelona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States France Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M99-049

Identifier Type: -

Identifier Source: org_study_id

NCT00006210

Identifier Type: -

Identifier Source: nct_alias