Infection, Human Immunodeficiency VirusPhase 2NCT00398125
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
A Phase 2 study testing GSK364735 in people with Infection, Human Immunodeficiency Virus and HIV-1 Infection, run by GlaxoSmithKline at 12 sites in United States.
Trial summary
To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infection, Human Immunodeficiency Virus, HIV-1 Infection
- What is being tested?
- GSK364735
- How many people
- 30 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2006to Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
- Baseline CD4 cell count greater than 100.
- Females must be of non-childbearing potential
- Not have received antiretroviral therapy in the 12 weeks prior to first dose.
Who cannot join
- Must not be infected with hepatitis B or C.
- Patients must not have any acute laboratory abnormality.
- Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Hollywood, Florida, 33020
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Newark, New Jersey, 07102
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
San Diego, California, 92103
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults.
To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults
- Being tested
- GSK364735
- Keywords
- GSK364735, HIV-1, integrase inhibitor
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK364735Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load
Measured: from Day 1 to Day 11
Amount of drug in blood
Measured: on Days 1 and 10.
Secondary outcomes (1)
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startNov 2006
- Study completionApr 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 VirusStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398125
- Sponsor's protocol ID
- GRZ107460
- Status last verified
- Jul 2012
- First submitted
- 8 Nov 2006
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults.
- ClinicalTrials.gov ID
- NCT00398125
- Acronym / sponsor ID
- GRZ107460
- Keywords
- GSK364735, HIV-1, integrase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 10 Nov 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.
To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
- Baseline CD4 cell count greater than 100.
- Females must be of non-childbearing potential
- Not have received antiretroviral therapy in the 12 weeks prior to first dose.
Key exclusion criteria (3 listed)
- Must not be infected with hepatitis B or C.
- Patients must not have any acute laboratory abnormality.
- Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.
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 |
|---|---|---|
| GSK364735 | Drug | – |
Primary outcome
Change in viral load
Time frame: from Day 1 to Day 11
Amount of drug in blood
Time frame: on Days 1 and 10.
1 secondary outcome
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
Time frame: throughout the study
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 30 Jul 2012.
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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 study director
GlaxoSmithKline
12 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 GSK364735 in people with Infection, Human Immunodeficiency Virus and HIV-1 Infection, run by GlaxoSmithKline at 12 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 4 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 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Change in viral load (time frame: from Day 1 to Day 11). The study lists 2 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 Jul 2012.