HIV InfectionPhase 3NCT00197197
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-Tropic Treatment-Experienced HIV-Infected Subjects
A Phase 3 study testing GW873140 in people with HIV Infection, run by GlaxoSmithKline at 12 sites in 2 countries.
Trial summary
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/X4-tropic virus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- GW873140
- How many people
- 18 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jul 2005to Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected.
- Screening viral load at least 5000copies/mL.
- R5/X4-tropic virus at screening.
- Total prior antiretroviral experience of at least 3 months.
- 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.
Who cannot join
- 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-tropic only.
- X4-tropic only.
- non-phenotypeable virus at screening.
- Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
Show all 12Show fewer
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Hollywood, Florida, 33020
GSK Investigational Site
Houston, Texas, 77027
GSK Investigational Site
Los Angeles, California, 90046
GSK Investigational Site
New Orleans, Louisiana, 70127-0800
GSK Investigational Site
Newark, New Jersey, 07102
GSK Investigational Site
Norwalk, Connecticut, 06851
GSK Investigational Site
Plantation, Florida, 33317
About this study
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.
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/X4-tropic virus
- Conditions
- HIV Infection
- Being tested
- GW873140
- Keywords
- HIV-1 GW873140 CCR5 antagonist treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW873140Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load response at 24 and 48 weeks.
Measured: 24 and 48 weeks
Secondary outcomes (1)
Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes.Liver tests will be done every 2 weeks for 24 weeks.
Measured: every 2 weeks for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionOct 2005
- Study completionOct 2005
Why it stopped: The study was terminated due to hepatoxicity of compound
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Ph.D., Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197197
- Sponsor's protocol ID
- CCR104458
- Status last verified
- Mar 2011
- First submitted
- 12 Sep 2005
- Last updated
- 29 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00197197
- Acronym / sponsor ID
- CCR104458
- Conditions
- HIV Infection
- Keywords
- HIV-1 GW873140 CCR5 antagonist treatment experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to hepatoxicity of compound
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/X4-tropic virus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-infected.
- Screening viral load at least 5000copies/mL.
- R5/X4-tropic virus at screening.
- Total prior antiretroviral experience of at least 3 months.
- 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.
Key exclusion criteria (12 listed)
- 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-tropic only.
- X4-tropic only.
- non-phenotypeable virus at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW873140 | Drug | – |
Primary outcome
HIV viral load response at 24 and 48 weeks.
Time frame: 24 and 48 weeks
1 secondary outcome
Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes.Liver tests will be done every 2 weeks for 24 weeks.
Time frame: every 2 weeks for 24 weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to hepatoxicity of compound). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, Ph.D. study director
GlaxoSmithKline
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GW873140 in people with HIV Infection, run by GlaxoSmithKline at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to hepatoxicity of compound). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral load response at 24 and 48 weeks. (time frame: 24 and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.