Infection, Human Immunodeficiency Virus IPhase 2NCT00102778
GW873140 In Combination With Kaletra In HIV Infected Subjects
A Phase 2 study testing GW873140 and Kaletra (lopinavir/ritonavir) in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 70 sites in 10 countries.
Trial summary
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus I, HIV Infection
- What is being tested?
- GW873140 and Kaletra (lopinavir/ritonavir)
- How many people
- 175 participants
- Where
- 70 sitesin 10 countries
- Study dates
- Dec 2004to Sep 2007
- Phase
- Phase 2
- 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, therapy-naive subjects.
- Females must be of either non-childbearing age, or have a negative pregnancy test.
- All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
- Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
- Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.
- Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).
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- Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.
- Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.
- Signed and dated written informed consent prior to study entry.
Who cannot join
- No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening.
- No active Class C AIDS-defining illness.
- No laboratory abnormalities at screen.
- No significant blood loss prior to study start.
- No pregnant or breastfeeding women.
- Additional qualifying criteria to be determined by the physician.
Trial locations and contacts
70 sites in 10 countries.
70 sites in 10 countries
United States32 sites
GSK Investigational Site
Allentown, Pennsylvania, 18103
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Bradenton, Florida, 34205
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Chicago, Illinois, 60613
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Fort Lauderdale, Florida, 33306
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Myers, Florida, 33901
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Houston, Texas, 77027
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Long Beach, California, 90813
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Los Angeles, California, 90069
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
New Orleans, Louisiana, 70127-0800
GSK Investigational Site
New York, New York, 10014
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Philadelphia, Pennsylvania, 19102
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Portland, Oregon, 97209
GSK Investigational Site
San Francisco, California, 94115-1931
GSK Investigational Site
Santa Fe, New Mexico, 87505
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
Tucson, Arizona, 85745
GSK Investigational Site
Washington D.C., District of Columbia, 20007
GSK Investigational Site
Washington D.C., District of Columbia, 20036
GSK Investigational Site
West Palm Beach, Florida, 33408
France12 sites
GSK Investigational Site
Le Kremlin-Bicêtre, 94275
GSK Investigational Site
Marseille, 13005
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75018
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Paris, 75571
GSK Investigational Site
Paris, 75651
GSK Investigational Site
Paris, 75679
GSK Investigational Site
Paris, 75970
GSK Investigational Site
Saint-Denis, 93205
GSK Investigational Site
Tourcoing, 59208
GSK Investigational Site
Villejuif, 94804
Germany6 sites
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Hamburg, 20099
GSK Investigational Site
Hamburg, 20146
Canada5 sites
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Toronto, Ontario, M5G 2N2
GSK Investigational Site
Vancouver, British Columbia, V6Z 2C7
United Kingdom5 sites
GSK Investigational Site
Birmingham, Warwickshire, B29 6JD
GSK Investigational Site
Brighton, Sussex East, BN2 1ES
GSK Investigational Site
London, EC1 7BE
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
Manchester, Lancashire, M8 5RB
Italy3 sites
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Turin, Piedmont, 10149
Denmark2 sites
GSK Investigational Site
Copenhagen, DK-2100
GSK Investigational Site
Hvidovre, DK-2650
Portugal2 sites
GSK Investigational Site
Cascais, 2750
GSK Investigational Site
Lisbon, 1150
Spain2 sites
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Seville, 41013
About this study
Official title: A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.
Read the detailed description
A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects
- Being tested
- GW873140, Kaletra (lopinavir/ritonavir)
- Keywords
- HIV infected, therapy-naive subjects
- Medical subject headings
- Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW873140Drug
Kaletra (lopinavir/ritonavir)Drug
Also called GW873140
What is being measured
The primary outcome is the main question the study is designed to answer.
To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.
Secondary outcomes (1)
HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startDec 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102778
- Sponsor's protocol ID
- 100136
- Status last verified
- May 2017
- First submitted
- 1 Feb 2005
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects
- ClinicalTrials.gov ID
- NCT00102778
- Acronym / sponsor ID
- 100136
- Keywords
- HIV infected, therapy-naive subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 175 participants
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Feb 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.
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.
Detailed description
A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV infected, therapy-naive subjects.
- Females must be of either non-childbearing age, or have a negative pregnancy test.
- All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
- Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
- Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.
Key exclusion criteria (6 listed)
- No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening.
- No active Class C AIDS-defining illness.
- No laboratory abnormalities at screen.
- No significant blood loss prior to study start.
- No pregnant or breastfeeding women.
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 | – |
| Kaletra (lopinavir/ritonavir)Also: GW873140 | Drug | – |
Primary outcome
To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.
1 secondary outcome
HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy.
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 30 May 2017.
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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, MD study director
GlaxoSmithKline
70 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW873140 and Kaletra (lopinavir/ritonavir) in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 70 sites in 10 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 9 inclusion and 6 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, France, Germany, Canada, United Kingdom and 5 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.. 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 30 May 2017.