Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART - Tabular View

Tracking Information

First Received Date ^ICMJE

May 31, 2002

Last Updated Date

March 29, 2008

Start Date ^ICMJE

April 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00038532 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

Official Title ^ICMJE

An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

Brief Summary

The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Amprenavir/ritonavir
Drug: Saquinavir/ritonavir
Drug: Efavirenz

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion:

Remain on present anti-HIV drugs during screening until a new regimen is started.
Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
Have an HIV which shows reduced susceptibility to lopinavir.
Are at least 18 years old.
Are not presently ill.
Have not been treated for an opportunistic infection within 30 days of screening.
Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.
Agree to use an accepted barrier method of birth control.

Exclusion:

Female subject is pregnant or lactating.
Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
Are taking chemotherapy.
Have a medical problem with their pancreas.
Have been screened for this study within the past 12 weeks.
Appear to be unsuitable in the opinion of the doctor.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Canada, France, Germany, Italy, Poland, Puerto Rico, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00038532

Responsible Party

Study ID Numbers ^ICMJE

M01-287

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Eugene Sun, M.D.

Divisional Vice President, Infectious Diseases and Virology Development

Information Provided By

Abbott

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP