Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140
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ClinicalTrials.gov Identifier: NCT00123890 |
Recruitment Status
:
Terminated
(The study was terminated due to hepatoxicity of compound)
First Posted
: July 26, 2005
Last Update Posted
: March 29, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: GW873140 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
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. |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

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

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

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

Study Director: | GSK Clinical Trials, Ph.D. | GlaxoSmithKline |
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00123890 History of Changes |
Other Study ID Numbers: |
CCR104627 |
First Posted: | July 26, 2005 Key Record Dates |
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 |