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

This study has been completed.

First Received: May 31, 2002 Last Updated: March 29, 2008 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00038532

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Amprenavir/ritonavir Drug: Saquinavir/ritonavir Drug: Efavirenz	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Saquinavir Saquinavir mesylate Efavirenz Ritonavir VX 478

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	April 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038532

Show 54 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Chair:

Eugene Sun, M.D.

Divisional Vice President, Infectious Diseases and Virology Development

More Information

No publications provided

Study ID Numbers:	M01-287
Study First Received:	May 31, 2002
Last Updated:	March 29, 2008
ClinicalTrials.gov Identifier:	NCT00038532 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

treatment experienced
HIV

Study placed in the following topic categories:

Efavirenz
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Saquinavir
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Protease Inhibitors

Virus Diseases
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Antitubercular Agents
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Saquinavir
Infection
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
RNA Virus Infections

HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009