Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects
This study has been terminated.
(The study was terminated due to hepatoxicity of compound)
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197145
First received: September 13, 2005
Last updated: March 28, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5-tropic virus
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Drug: GW873140 |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Compare the Efficacy and Safety of GW873140 400mg BID in Combination With a Ritonavir-containing Optimized Background Therapy (OBT) Regimen Versus Placebo Plus OBT Over 48 Weeks. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- HIV viral load response at 24 and 48 weeks as measured by proportion of subjects with undetectable viral load, change from baseline over time, proportion of subjects with 1.0 log drop, and time to virologic failure. [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes, and adherence will be determined over 24 and 48 weeks. Liver tests will be done every 2 weeks for 24 weeks. [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
Enrollment: | 23 |
Study Start Date: | July 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: GW873140
Other Name: GW873140
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.
- R5-tropic only virus at screening.
- 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.
- R5/X4-tropic, X4-tropic only, or non-phenotypeable virus at screening.
- Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
- 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: NCT00197145
Locations
United States, Alabama | |
GSK Investigational Site | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
GSK Investigational Site | |
Los Angeles, California, United States, 90046 | |
GSK Investigational Site | |
Oakland, California, United States, 94609 | |
GSK Investigational Site | |
Tarzana, California, United States, 30342 | |
United States, Connecticut | |
GSK Investigational Site | |
Glastonbury, Connecticut, United States, 06033 | |
GSK Investigational Site | |
Norwalk, Connecticut, United States, 06851 | |
United States, Florida | |
GSK Investigational Site | |
Fort Lauderdale, Florida, United States, 33308 | |
GSK Investigational Site | |
Ft. Lauderdale, Florida, United States, 33306 | |
GSK Investigational Site | |
Orlando, Florida, United States, 32804 | |
GSK Investigational Site | |
Plantation, Florida, United States, 33317 | |
United States, Georgia | |
GSK Investigational Site | |
Atlanta, Georgia, United States, 30339 | |
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
GSK Investigational Site | |
New Orleans, Louisiana, United States, 70127-0800 | |
United States, Maryland | |
GSK Investigational Site | |
Baltimore, Maryland, United States, 21201 | |
United States, New Jersey | |
GSK Investigational Site | |
Newark, New Jersey, United States, 07102 | |
United States, Ohio | |
GSK Investigational Site | |
Akron, Ohio, United States, 44304 | |
Canada, Ontario | |
GSK Investigational Site | |
Toronto, Ontario, Canada, M5B 1L6 |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: | GSK Clinical Trials, Ph.D. | GlaxoSmithKline |
More Information
No publications provided
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00197145 History of Changes |
Other Study ID Numbers: | CCR102709 |
Study First Received: | September 13, 2005 |
Last Updated: | March 28, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
HIV-1 GW873140 CCR5 antagonist experienced |
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 |
ClinicalTrials.gov processed this record on October 16, 2012