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Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140

This study has been terminated.

(The study was terminated due to hepatoxicity of compound)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00123890

First Posted: July 26, 2005

Last Update Posted: March 29, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

GlaxoSmithKline

Purpose

The purpose of this study is to determine eligibility for one of three treatment studies of the CCR5 antagonist GW873140 or an observational study without GW873140. No investigational treatment will be administered through this study.

Condition	Intervention	Phase
HIV Infection	Drug: GW873140	Phase 3


Study Type:	Interventional
Study Design:	Masking: None (Open Label) Primary Purpose: Diagnostic
Official Title:	A Screening Protocol to Determine Eligibility for One of Three Phase III Treatment Studies Evaluating the Efficacy and Safety of GW873140 in R5-tropic and R5/X4-tropic HIV-1 Infected, Treatment-experienced Subjects With Drug-resistant Virus or an Observational Study.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629.


Enrollment:	0
Study Start Date:	June 2005
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Criteria

Inclusion Criteria:

HIV-infected.
Screening viral load at least 5000copies/mL.
Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
Women of childbearing potential must use specific forms of contraception.

Exclusion criteria:

Acute laboratory abnormalities.
History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment or observational studies.
Pregnancy or breastfeeding women.
Recent participation in an experimental drug trial.
Prior use of a CCR5 or CXCR4 antagonist.
Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
Current use of certain medications may exclude participation in this study.
Additional qualifying criteria and laboratory test requirements to be assessed by study physician.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123890

Show 42 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, Ph.D.	GlaxoSmithKline

More Information


Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00123890 History of Changes
Other Study ID Numbers:	CCR104627
First Submitted:	July 22, 2005
First Posted:	July 26, 2005
Last Update Posted:	March 29, 2011
Last Verified:	March 2011

Keywords provided by GlaxoSmithKline:


HIV-1 GW873140 CCR5 antagonist experienced

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

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