Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor - Full Text View

Purpose

The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

Condition	Intervention	Phase
HIV Infections	Drug: Amprenavir/ritonavir Drug: Saquinavir/ritonavir	Phase 2 Phase 3


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 or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Proteinase inhibitor Saquinavir Saquinavir mesylate Ritonavir Amprenavir

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:	16
Study Start Date:	April 2001

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
Subject demonstrates reduced susceptibility to lopinavir.
Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
Subject is at least 18 years of age.
Subject has not been treated for an active opportunistic infection within 30 days of screening.

Exclusion:

Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
Female subject pregnant or lactating.
Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
Subject is receiving systemic chemotherapy.
Subject has a history of acute or chronic pancreatitis.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038519

Show 52 Study Locations

Sponsors and Collaborators

Abbott

Investigators


Study Chair:	Eugene Sun, M.D.	Divisional Vice President, Infectious Diseases and Virology Development

More Information


ClinicalTrials.gov Identifier:	NCT00038519 History of Changes
Other Study ID Numbers:	M00-261
Study First Received:	May 31, 2002
Last Updated:	July 27, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:


treatment experienced HIV

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir HIV Protease Inhibitors Saquinavir Amprenavir	Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 23, 2016