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 on May 31, 2002. Last Updated on March 29, 2008 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

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

U.S. FDA Resources

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

ClinicalTrials.gov Identifier:	NCT00038532 History of Changes
Obsolete Identifiers:	NCT00021619
Other Study ID Numbers:	M01-287
Study First Received:	May 31, 2002
Last Updated:	March 29, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

treatment experienced
HIV

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Saquinavir
Ritonavir
Amprenavir

Efavirenz
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012