Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects

A Phase 3 study testing GW873140 in people with HIV Infection, run by GlaxoSmithKline at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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-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: 406 participants
Where: 5 sitesGermany
Study dates: Jul 2005to Oct 2007
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

The following are study specific eligibility criteria. In addition to these criteria, investigators must exercise clinical discretion regarding selection of appropriate study subjects, taking into consideration any local treatment practices or guidelines.
A subject will be eligible for inclusion in the CCR104456 protocol only if all of the following criteria apply:
HIV-1 infected subjects aged 18 years or older. All subjects participating in this study should be counseled on the practice of safe sex throughout the study. Females must fall into one of the following categories:
Non-childbearing potential: defined as women who are surgically sterile or post-menopausal, the latter indicated by history of no menses for a minimum of one year prior to the date of the screening visit; Childbearing potential: has a negative pregnancy test result (-human chorionic gonadotropin; -HCG) within 35 days prior to administration of investigational product (Day 1) and agrees to use a proven double barrier method of contraception (e.g. spermicide + condom) during the study period (through follow-up). Hormonal contraceptives will not be considered sufficient forms of contraception for this study.
Screening plasma HIV-1 RNA ≥5000copies/mL (from CCR104627 protocol). There are no CD4 cell count entry restrictions, however investigators must exercise clinical discretion regarding selection of appropriate study subjects, taking into consideration any local treatment practices or guidelines regarding CD4 cell count and HIV-1 RNA.
Total prior antiretroviral experience of at least three months and documented genotypic or phenotypic resistance to at least one compound in each of the following classes of antiretrovirals: NRTIs (includes NtRTI TDF), NNRTIs, and PIs. Resistance mutations must be at least one major mutation according to the current International AIDS Society-USA Drug Resistance Mutations Group (refer to study reference manual [SRM]). Resistance testing may be current (e.g. screening results) and/or historical with verifiable documentation in source documents.

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R5-tropic virus according to viral tropism assessment at screening in CCR104627 protocol.
Current receipt of an unchanged "pre-study" ART regimen (i.e., unchanged medications and doses) for at least four weeks prior to screening in CCR104627 protocol; this pre-study regimen may be no ART. Subjects must remain on this regimen until randomization (Day 1).
Subjects must be able to receive a RTV-boosted PI as part of their OBT regimen. Due to the possibility of randomization to the placebo arm, investigators should consider subjects for enrollment whose treatment history and resistance testing results suggest that an OBT regimen can be constructed which would be anticipated to provide the best possible virological response and clinical benefit for each subject. The drugs in the OBT regimen will be chosen from the locally available antiretrovirals and must consist of between three and six drugs, one of which must be a RTV-boosted PI. Use of investigational PIs which become available through expanded-access or similar programs during the conduct of this study must be authorized by the Sponsor prior to use in OBT regimen.
Ability to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Signed and dated written informed consent prior to initiation of pre-baseline study procedures.

Who cannot join

A subject will not be eligible for inclusion in the CCR104456 protocol if any of the following criteria apply:
Plasma sample tests as R5/X4 (dual or mixed)-tropic, X4-tropic only, or non-phenotypeable based on viral tropism assessment at screening in protocol CCR104627.
Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. Any Grade 4 laboratory abnormality at screening will exclude a subject from study participation unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the Sponsor.
Subjects that make any changes to their ART regimen during the period beginning four weeks prior to screening (protocol CCR104627) until Day 1.
Significant blood loss (≥500mL) within 56 days prior to screening in CCR104627 protocol.
Pregnant women or women who are breastfeeding.

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Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer, prior to screening for the study.
Subjects with any prior receipt of an investigational CCR5 or CXCR4 antagonist are excluded.
Any clinically significant finding on screening or baseline ECG. Specifically, subjects with any repolarization delay (resting QTcB interval >450msec at the screening or baseline [mean of triplicate values] visit) will be excluded. Subjects with a history of additional risk factors for torsade de pointes (e.g., heart failure, chronic and/or recurrent hypokalemia) will also be excluded.
History of clinically relevant pancreatitis or hepatitis within the previous 6 months. Asymptomatic individuals with chronic hepatitis B (HBV) or hepatitis C virus (HCV) infection will not be excluded, however investigators should carefully assess if antiviral therapy specifically for HBV or HCV infection is required; subjects who are anticipated to require such therapy during the study should be excluded.
Any condition which, in the opinion of the investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations (including alcohol or drug abuse) or which might compromise the safety of the subject.
Any evidence of active CDC Class C conditions or opportunistic infections. Subjects on stable, anti-infective treatment or prophylaxis regimen are allowed in the study provided the therapy is not specifically prohibited.
Any condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject's participation in the study or known hypersensitivity to any study medication or excipients.
Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of investigational product administration or anticipated need for such treatment during the study.
Current severe illness, including liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which would make the subject unsuitable for the study. Subjects with basal cell carcinoma of the skin, in situ carcinoma of the cervix, or non-disseminated stable Kaposi's sarcoma may be included in the trial.
Use of systemic immunosuppressants and/or immunomodulators within 30 days prior to study Day 1. Systemic corticosteroids at replacement doses (e.g. 10mg/day prednisone or equivalent) are permitted.
Anticipated continued need for prescription or over-the-counter (OTC) medications that are on the prohibited medication list within 30 days prior to study Day 1.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

GSK Investigational Site
Berlin, State of Berlin, 13353
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Hanover, Lower Saxony, 30625

Other trials in Germany

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.

Conditions: HIV Infection
Being tested: GW873140
Keywords: HIV-1, GW873140, CCR5 antagonist, experienced, 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 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.

Secondary outcomes (2)

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.
Proportion of subjects with plasma HIV-1 RNA <400copies/mL at Week 24 and 48 based on the outcomes from the TLOVR algorithm.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Oct 2007

First posted27 Feb 2006 (estimated)
Study startJul 2005
Primary completionOct 2007 (estimated)
Study completionOct 2007 (estimated)

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: Double blind
Enrolment: 406 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00297076
Sponsor's protocol ID: CCR104456
Status last verified: May 2009
First submitted: 24 Feb 2006
Last updated: 18 May 2009
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2009. 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: NCT00297076
Acronym / sponsor ID: CCR104456
Conditions: HIV Infection
Keywords: HIV-1, GW873140, CCR5 antagonist, experienced, Treatment Experienced
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 406 participants
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Oct 2007 (estimated)
Study completion: Oct 2007 (estimated)
First posted: 27 Feb 2006 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

The following are study specific eligibility criteria. In addition to these criteria, investigators must exercise clinical discretion regarding selection of appropriate study subjects, taking into consideration any local treatment practices or guidelines.
A subject will be eligible for inclusion in the CCR104456 protocol only if all of the following criteria apply:
HIV-1 infected subjects aged 18 years or older. All subjects participating in this study should be counseled on the practice of safe sex throughout the study. Females must fall into one of the following categories:
Non-childbearing potential: defined as women who are surgically sterile or post-menopausal, the latter indicated by history of no menses for a minimum of one year prior to the date of the screening visit; Childbearing potential: has a negative pregnancy test result (-human chorionic gonadotropin; -HCG) within 35 days prior to administration of investigational product (Day 1) and agrees to use a proven double barrier method of contraception (e.g. spermicide + condom) during the study period (through follow-up). Hormonal contraceptives will not be considered sufficient forms of contraception for this study.
Screening plasma HIV-1 RNA ≥5000copies/mL (from CCR104627 protocol). There are no CD4 cell count entry restrictions, however investigators must exercise clinical discretion regarding selection of appropriate study subjects, taking into consideration any local treatment practices or guidelines regarding CD4 cell count and HIV-1 RNA.

Key exclusion criteria (18 listed)

A subject will not be eligible for inclusion in the CCR104456 protocol if any of the following criteria apply:
Plasma sample tests as R5/X4 (dual or mixed)-tropic, X4-tropic only, or non-phenotypeable based on viral tropism assessment at screening in protocol CCR104627.
Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. Any Grade 4 laboratory abnormality at screening will exclude a subject from study participation unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the Sponsor.
Subjects that make any changes to their ART regimen during the period beginning four weeks prior to screening (protocol CCR104627) until Day 1.
Significant blood loss (≥500mL) within 56 days prior to screening in CCR104627 protocol.

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 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.

2 secondary outcomes

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.
Proportion of subjects with plasma HIV-1 RNA <400copies/mL at Week 24 and 48 based on the outcomes from the TLOVR algorithm.

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.

Related trials for HIV Infection

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections

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

5 sites in 1 country: 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 5 sites in Germany.

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 11 inclusion and 18 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 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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. 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 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00297076.

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 18 May 2009; AzTrials last refreshed its copy on 8 Nov 2026.