Infection, Human Immunodeficiency Virus IPhase 2NCT00104429
GW873140 In Combination With Combivir In HIV Infected Subjects
A Phase 2 study testing GW873140 and Combivir in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 51 sites in 9 countries.
Trial summary
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir 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 Combivir
- How many people
- 125 participants
- Where
- 51 sitesin 9 countries
- Study dates
- Jan 2005to Jan 2006
- 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 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 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
- Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit.
- Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
Show all 10Show fewer
- Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a 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).
- 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
- Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening.
- Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
- Active Class C AIDS-defining illness.
- Laboratory abnormalities at screen.
- Significant blood loss prior to study start.
- Pregnant or breastfeeding women.
- Additional qualifying criteria to be determined by the physician.
Trial locations and contacts
51 sites in 9 countries.
51 sites in 9 countries
United States27 sites
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Boston, Massachusetts, 02114
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Conyers, Georgia, 30013
GSK Investigational Site
Dallas, Texas, 75208
GSK Investigational Site
Dallas, Texas, 75215
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80205
GSK Investigational Site
Las Vegas, Nevada, 89102
GSK Investigational Site
Los Angeles, California, 90022
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Minneapolis, Minnesota, 55404
GSK Investigational Site
New York, New York, 10008
GSK Investigational Site
Newark, New Jersey, 7102
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Providence, Rhode Island, 02908
GSK Investigational Site
Rochester, New York, 14604
GSK Investigational Site
San Francisco, California, 94114
GSK Investigational Site
Stanford, California, 94305
GSK Investigational Site
Tampa, Florida, 33607
GSK Investigational Site
Tarzana, California, 30342
GSK Investigational Site
Vero Beach, Florida, 32960
GSK Investigational Site
Washington D.C., District of Columbia, 20009
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, SW10 9TH
GSK Investigational Site
Manchester, Lancashire, M8 5RB
Canada4 sites
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Montreal, Quebec, H2L 5B1
GSK Investigational Site
Ottawa, Ontario, K1N 6N5
GSK Investigational Site
Toronto, Ontario, M4N 3M5
France4 sites
GSK Investigational Site
Levallois-Perret, 92300
GSK Investigational Site
Lyon, 69288
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75018
Germany3 sites
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Würzburg, Bavaria, 97080
Italy3 sites
GSK Investigational Site
Brescia, Lombardy, 25125
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Milan, Lombardy, 20157
Portugal3 sites
GSK Investigational Site
Coimbra, 3000-075
GSK Investigational Site
Lisbon, 1169-100
GSK Investigational Site
Porto, 4200-319
About this study
Official title: A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.
Read the detailed description
A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults
- Being tested
- GW873140, Combivir
- Keywords
- HIV infections, therapy naive
- 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
CombivirDrug
Also called GW873140
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12
Secondary outcomes (1)
- Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2006
- Study completionJan 2006
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
- 125 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
- NCT00104429
- Sponsor's protocol ID
- 102881
- Status last verified
- May 2017
- First submitted
- 28 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 PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults
- ClinicalTrials.gov ID
- NCT00104429
- Acronym / sponsor ID
- 102881
- Keywords
- HIV infections, therapy naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 125 participants
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 1 Mar 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 Combivir in HIV infected, untreated subjects.
Detailed description
A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults
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 (10 listed)
- HIV infected 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 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
- Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit.
Key exclusion criteria (7 listed)
- Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening.
- Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
- Active Class C AIDS-defining illness.
- Laboratory abnormalities at screen.
- Significant blood loss prior to study start.
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 | – |
| CombivirAlso: GW873140 | Drug | – |
Primary outcome
Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12
1 secondary outcome
- Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.
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
51 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW873140 and Combivir in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 51 sites in 9 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 10 inclusion and 7 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 51 sites in United States, United Kingdom, Canada, France, Germany and 4 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?
Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12. 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.