NCT00038636

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3 hiv-infections

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2002

Completed
Last Updated

August 15, 2006

Status Verified

August 1, 2006

First QC Date

June 3, 2002

Last Update Submit

August 13, 2006

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts

Interventions

Lopinavir/ritonavirDRUG
RitonavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UCSD Treatment Center

San Diego, California, 92103-6329, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Hopital Pitie-Salpetriere

Paris, 75651, France

Location

Hospital Europeen Georges Pompidou

Paris, 75908, France

Location

Hospital Clinico de Barcelona

Barcelona, 08036, Spain

Location

Ciutat Sanitaria de Bellvitge

Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

LopinavirRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Eugene Sun, M.D.

    Divisional Vice President, Infectious Diseases and Virology Dept.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 3, 2002

First Posted

June 4, 2002

Study Start

September 1, 2000

Last Updated

August 15, 2006

Record last verified: 2006-08

Locations

FR(2)US(3)ES(2)