Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2002 by NIH AIDS Clinical Trials Information Service. Recruitment status was Active, not recruiting

First Received on October 15, 2001. Last Updated on June 23, 2005 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00025727

Purpose

The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Ritonavir Drug: GW433908	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Ritonavir Lopinavir Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	330
Study Start Date:	May 2001

Detailed Description:

Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Have a viral load of 1,000 or more copies/ml.
Have taken protease inhibitors (PIs).
Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.
Are now taking antiretroviral therapy.
Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18.
Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have taken APV or LPV for more than 1 week.
Have taken tenofovir disoproxil fumarate (TDF) or adefovir.
Have taken more than 2 PIs.
Are unable to take 2 active RTIs, as specified by the study.
Have an active CDC Category C disease.
Have certain abnormal laboratory tests.
Are pregnant or breast-feeding.
Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient.
Have a history of significant kidney or bone disease.
Are not able to take drugs by mouth and cannot absorb them.
Have had pancreatitis or hepatitis within the previous 6 months.
Have a drug allergy or other allergy which might cause a problem during the study.
Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study.
Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug.
Have had any HIV vaccine within 3 months before taking the study drug.
Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study.
Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study.
Are not able to take the study drugs.
Have inadequate kidney function.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025727

Show 32 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00025727 History of Changes
Other Study ID Numbers:	316C
Study First Received:	October 15, 2001
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
HIV Protease Inhibitors
Ritonavir
RNA, Viral

Anti-HIV Agents
Viral Load
ABT 378
VX-175

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

Ritonavir
Lopinavir
Fosamprenavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012