Infection, Human Immunodeficiency Virus IPhase 2NCT00242879
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
A Phase 2 study testing Physician determined comparator PI + ritonavir and GW640385 + ritonavir in people with Infection, Human Immunodeficiency Virus I and HIV-1 Infection, run by ViiV Healthcare at 70 sites in 11 countries.
Trial summary
This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. 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-1 Infection
- What is being tested?
- Physician determined comparator PI + ritonavir and GW640385 + ritonavir
- How many people
- 130 participants
- Where
- 70 sitesin 11 countries
- Study dates
- Aug 2005to Jun 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
- 18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
- HIV-1 infected subjects.
- Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
- Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.
- Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
- Subjects must have been receiving the same anti-HIV medicines that they are on currently for at least 8 weeks prior to Screening; these anti-HIV medicines will include a single protease inhibitor (PI) in combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.
- Able to understand and follow protocol requirements, instructions and protocol-stated restrictions.
- Be willing and able to provide signed and dated written informed consent prior to study entry.
Who cannot join
- Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
- Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
- Active CDC Class C disease at screening.
- Pregnant or breastfeeding women.
- Protocol-specified laboratory abnormalities at Screening.
Trial locations and contacts
70 sites in 11 countries.
70 sites in 11 countries
United States31 sites
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Bradenton, Florida, 34205
GSK Investigational Site
Chicago, Illinois, 60612-7230
GSK Investigational Site
Chicago, Illinois, 60613
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80204
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Fort Lauderdale, Florida, 33306
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Greenville, South Carolina, 29605
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Houston, Texas, 77027
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Las Vegas, Nevada, 89102
GSK Investigational Site
Los Angeles, California, 90046
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Miami Beach, Florida, 33140
GSK Investigational Site
Newark, New Jersey, 7102
GSK Investigational Site
Norwalk, Connecticut, 06851
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Rochester, New York, 14604
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
San Francisco, California, 94121
GSK Investigational Site
Washington D.C., District of Columbia, 20007
GSK Investigational Site
Washington D.C., District of Columbia, 20009
France7 sites
GSK Investigational Site
Caen, 14000
GSK Investigational Site
La Roche-sur-Yon, 85025
GSK Investigational Site
Lyon, 69288
GSK Investigational Site
Lyon, 69437
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Paris, 75571
Italy7 sites
GSK Investigational Site
Bagno A Ripoli (FI), Tuscany, 50126
GSK Investigational Site
Bari, Apulia, 70124
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Rimini, Emilia-Romagna, 47900
GSK Investigational Site
Turin, Piedmont, 10149
Canada6 sites
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Montreal, Quebec, H2X 2P4
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M5B 1L6
GSK Investigational Site
Vancouver, British Columbia, V6Z 2C7
Germany6 sites
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Hamburg, 20099
GSK Investigational Site
Munich, Bavaria, 80335
Australia3 sites
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Liverpool, New South Wales, 2170
GSK Investigational Site
South Yarra, Victoria, 3141
Romania3 sites
GSK Investigational Site
Bucharest, 021105
GSK Investigational Site
Constanța, 900709
GSK Investigational Site
Iași, 700116
Portugal2 sites
GSK Investigational Site
Cascais, 2750
GSK Investigational Site
Lisbon, 1150
Puerto Rico2 sites
GSK Investigational Site
Ponce, 00731
GSK Investigational Site
San Juan, 00909-1711
United Kingdom2 sites
GSK Investigational Site
London, EC1 7BE
GSK Investigational Site
London, SW10 9TH
About this study
Official title: Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen
This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.
Read the detailed description
A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen
- Being tested
- Physician determined comparator PI + ritonavir, GW640385 + ritonavir
- Keywords
- treatment-experienced, RTV, protease inhibitor, ritonavir, GW640385, HIV-1
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician determined comparator PI + ritonavirDrug
GW640385 + ritonavirDrug
Also called Physician determined comparator PI + ritonavir
What is being measured
The primary outcome is the main question the study is designed to answer.
Time averaged change in plasma HIV-1 RNA over 16 wks
Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels
Change in laboratory parameters
Secondary outcomes (7)
Assessments of HIV viral load changes
GW640385 and RTV pharmacokinetic measurements
The incidence of adverse events
Changes in laboratory measurements
ECG measurements
HIV viral resistance assessment
Immunologic measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2007
- Study completionJun 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
- 130 participants (actual)
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
- NCT00242879
- Sponsor's protocol ID
- HPR20001
- Status last verified
- May 2017
- First submitted
- 19 Oct 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
- Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen
- ClinicalTrials.gov ID
- NCT00242879
- Acronym / sponsor ID
- HPR20001
- Keywords
- treatment-experienced, RTV, protease inhibitor, ritonavir, GW640385, HIV-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 130 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 21 Oct 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 is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.
Detailed description
A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen
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 (8 listed)
- 18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
- HIV-1 infected subjects.
- Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
- Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.
- Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
Key exclusion criteria (5 listed)
- Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
- Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
- Active CDC Class C disease at screening.
- Pregnant or breastfeeding women.
- Protocol-specified laboratory abnormalities 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 |
|---|---|---|
| Physician determined comparator PI + ritonavir | Drug | – |
| GW640385 + ritonavirAlso: Physician determined comparator PI + ritonavir | Drug | – |
Primary outcome
Time averaged change in plasma HIV-1 RNA over 16 wks
Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels
Change in laboratory parameters
7 secondary outcomes
Assessments of HIV viral load changes
GW640385 and RTV pharmacokinetic measurements
The incidence of adverse events
Changes in laboratory measurements
ECG measurements
HIV viral resistance assessment
Immunologic measures
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 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physician determined comparator PI + ritonavir and GW640385 + ritonavir in people with Infection, Human Immunodeficiency Virus I and HIV-1 Infection, run by ViiV Healthcare at 70 sites in 11 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 8 inclusion and 5 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, Italy, Canada, Germany and 6 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?
Time averaged change in plasma HIV-1 RNA over 16 wks. The study lists 3 primary outcomes in all. 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.