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NCT00038636 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038636
Other study ID # M99-049
Secondary ID
Status Completed
Phase Phase 3
First received June 3, 2002
Last updated August 13, 2006
Start date September 2000

Study information
Verified date August 2006
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Other known NCT identifiers
  • NCT00006210

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lopinavir/ritonavir

• Ritonavir

Locations
Country Name City State
France Hopital Pitie-Salpetriere Paris
France Hospital Europeen Georges Pompidou Paris
Spain Ciutat Sanitaria de Bellvitge Barcelona
Spain Hospital Clinico de Barcelona Barcelona
United States Johns Hopkins Hospital Baltimore Maryland
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States UCSD Treatment Center San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
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