HIV InfectionsPhase 1NCT00090077
Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
A Phase 1 study testing GW695634 in people with HIV Infections, run by GlaxoSmithKline at 18 sites in United States.
Trial summary
To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients 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?
- GW695634
- How many people
- 50 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2004to not given
- Phase
- Phase 1
- 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
- CD4 cell count greater than or equal to 200 cells/mm3.
- HIV-1 RNA >2000 copies/mL.
- Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
- Normal resting 12-lead electrocardiogram.
Who cannot join
- Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.
- Chronic diarrhea (>3 loose stools/day).
- An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
- Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
- Any acute laboratory abnormality.
- Positive for HCV antibody or HepBsAG.
- Active infections requiring therapy in the previous 4 weeks.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
GSK Clinical Trials Call Center
Atlanta, Georgia, 30308
GSK Clinical Trials Call Center
Boston, Massachusetts, 02215
GSK Clinical Trials Call Center
Charlotte, North Carolina, 28209
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, 33308
GSK Clinical Trials Call Center
Fort Worth, Texas, 76104
GSK Clinical Trials Call Center
Fountain Valley, California, 92708
GSK Clinical Trials Call Center
Las Vegas, Nevada, 89102
GSK Clinical Trials Call Center
Miami, Florida, 33136
GSK Clinical Trials Call Center
Miami Beach, Florida, 33140
GSK Clinical Trials Call Center
New York, New York, 10008
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, 73104
GSK Clinical Trials Call Center
Orlando, Florida, 32804
GSK Clinical Trials Call Center
Phoenix, Arizona, 85006
GSK Clinical Trials Call Center
San Francisco, California, 94115
GSK Clinical Trials Call Center
Seattle, Washington, 98104
GSK Clinical Trials Call Center
Vero Beach, Florida, 32960
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 I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.
To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients
- Conditions
- HIV Infections
- Being tested
- GW695634
- Keywords
- GW695634G, GW695634X, GW678248X, pharmacokinetics, NNRTI, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW695634Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7
Secondary outcomes (1)
Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2004 (estimated)
- Study startApr 2004
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trial, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090077
- Sponsor's protocol ID
- NN210005
- Status last verified
- Feb 2006
- First submitted
- 24 Aug 2004
- Last updated
- 27 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.
- ClinicalTrials.gov ID
- NCT00090077
- Acronym / sponsor ID
- NN210005
- Conditions
- HIV Infections
- Keywords
- GW695634G, GW695634X, GW678248X, pharmacokinetics, NNRTI, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- First posted
- 26 Aug 2004 (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 antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients
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 (4 listed)
- CD4 cell count greater than or equal to 200 cells/mm3.
- HIV-1 RNA >2000 copies/mL.
- Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
- Normal resting 12-lead electrocardiogram.
Key exclusion criteria (7 listed)
- Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.
- Chronic diarrhea (>3 loose stools/day).
- An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
- Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
- Any acute laboratory abnormality.
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 |
|---|---|---|
| GW695634 | Drug | – |
Primary outcome
Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7
1 secondary outcome
Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments
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 27 Feb 2006.
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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 study director
GlaxoSmithKline
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW695634 in people with HIV Infections, run by GlaxoSmithKline at 18 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 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: finished, as of the sponsor's last update on 27 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7. 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 27 Feb 2006.