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CompletedNCT00038636Updated Aug 15, 2006

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

A Phase 3 interventional study of Lopinavir/ritonavir and Ritonavir in HIV Infections, sponsored by Abbott. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-08-15.

Sponsored by Abbott · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV
03

In context

HIV Infections

4,259 studies on the registry are indexed under HIV Infections; 241 are open to participants now.

This study's enrollment of 36 is below the median of 83 across 3,252 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants

Interventions

  • DrugLopinavir/ritonavir
  • DrugRitonavir
06

What researchers measure

Primary outcomes

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

07

Study locations

7 sites
  • UCSD Treatment Center
    San Diego, California 92103-6329, United States
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
  • The University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Hopital Pitie-Salpetriere
    Paris, 75651, France
  • Hospital Europeen Georges Pompidou
    Paris, 75908, France
  • Hospital Clinico de Barcelona
    Barcelona, 08036, Spain
  • Ciutat Sanitaria de Bellvitge
    Barcelona, 08907, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00038636
Lead sponsor
Abbott
First posted
Jun 4, 2002
Start date
Sep 2000
Last update
Aug 15, 2006

Study contacts

Eugene Sun, M.D.
study chair · Divisional Vice President, Infectious Diseases and Virology Dept.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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