HIV InfectionsPhase 2NCT00046332
A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
A Phase 2 study testing GW810781 in people with HIV Infections, run by GlaxoSmithKline at 23 sites in United States.
Trial summary
This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- GW810781
- How many people
- 100 participants
- Where
- 23 sitesUnited States
- Study dates
- Jun 2002to Jan 2003
- 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
- No prior HIV medications.
- HIV infection with viral load >400-50,000 copies/mL.
- CD4 cell count >50 cells/mm.
Who cannot join
- Patients requiring medications that cannot be interrupted for the duration of the study.
- Abnormal ECG or other chronic health conditions as noted on screening physical exam.
- Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this study.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
GSK Clinical Trials Call Center
Altamonte Springs, Florida, 32701
GSK Clinical Trials Call Center
Atlanta, Georgia, 30308
GSK Clinical Trials Call Center
Chapel Hill, North Carolina, 27599
GSK Clinical Trials Call Center
Charlotte, North Carolina, 28203
GSK Clinical Trials Call Center
Dallas, Texas, 75235
GSK Clinical Trials Call Center
Denver, Colorado, 80220
GSK Clinical Trials Call Center
Durham, North Carolina, 27710
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, 33311
GSK Clinical Trials Call Center
Houston, Texas, 77004
GSK Clinical Trials Call Center
Indianapolis, Indiana, 46202
GSK Clinical Trials Call Center
Los Angeles, California, 90048
GSK Clinical Trials Call Center
Miami, Florida, 33133
GSK Clinical Trials Call Center
Minneapolis, Minnesota, 55404
GSK Clinical Trials Call Center
New York, New York, 10008
GSK Clinical Trials Call Center
New York, New York, 10011
GSK Clinical Trials Call Center
New York, New York, 10032
GSK Clinical Trials Call Center
Phoenix, Arizona, 85006
GSK Clinical Trials Call Center
San Diego, California, 92103
GSK Clinical Trials Call Center
San Francisco, California, 94115
GSK Clinical Trials Call Center
Tampa, Florida, 33614
GSK Clinical Trials Call Center
The Bronx, New York, 10461
GSK Clinical Trials Call Center
Washington D.C., District of Columbia, 20007
GSK Clinical Trials Call Center
West Hollywood, California, 90069
About this study
Official title: A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.
This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.
- Conditions
- HIV Infections
- Being tested
- GW810781
- Keywords
- Integrase inhibitors, Monotherapy, HIV-1 infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW810781Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HIV-1 RNA change from baseline by Day 11.
Secondary outcomes (1)
HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2002 (estimated)
- Study startJun 2002
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi
- Investigators
- GSK Clinical Trial, MD,MPH, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046332
- Sponsor's protocol ID
- ITG20001
- Status last verified
- Feb 2013
- First submitted
- 26 Sep 2002
- Last updated
- 21 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.
- ClinicalTrials.gov ID
- NCT00046332
- Acronym / sponsor ID
- ITG20001
- Conditions
- HIV Infections
- Keywords
- Integrase inhibitors, Monotherapy, HIV-1 infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Shionogi
- Study start
- Jun 2002
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 30 Sep 2002 (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 will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.
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 (3 listed)
- No prior HIV medications.
- HIV infection with viral load >400-50,000 copies/mL.
- CD4 cell count >50 cells/mm.
Key exclusion criteria (3 listed)
- Patients requiring medications that cannot be interrupted for the duration of the study.
- Abnormal ECG or other chronic health conditions as noted on screening physical exam.
- Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this study.
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 |
|---|---|---|
| GW810781 | Drug | – |
Primary outcome
Plasma HIV-1 RNA change from baseline by Day 11.
1 secondary outcome
HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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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 Trial, MD,MPH study director
GlaxoSmithKline
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW810781 in people with HIV Infections, run by GlaxoSmithKline at 23 sites in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma HIV-1 RNA change from baseline by Day 11.. 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 21 Feb 2013.