Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140
This study has been terminated.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00123890
  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 Infections
Drug: GW873140
Phase III

MedlinePlus related topics: AIDS
Drug Information available for: Aplaviroc
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Uncontrolled, Safety/Efficacy Study
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629.

Estimated Enrollment: 1200
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123890

  Show 288 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, Ph.D. GlaxoSmithKline
  More Information

Study ID Numbers: CCR104627
Study First Received: July 22, 2005
Last Updated: November 21, 2005
ClinicalTrials.gov Identifier: NCT00123890  
Health Authority: United States: Food and Drug Administration;   Denmark: Danish Medicines Agency;   Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by GlaxoSmithKline:
HIV-1 GW873140 CCR5 antagonist experienced

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009