HIV InfectionsPhase 3NCT00043888
Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR
A Phase 3 study testing fosamprenavir, COMBIVIR and ritonavir in people with HIV Infections, run by GlaxoSmithKline at 18 sites in 3 countries.
Trial summary
Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- fosamprenavir, COMBIVIR and ritonavir
- How many people
- 60 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Jan 2002to May 2003
- Phase
- Phase 3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL.
- Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter.
- Antiretroviral therapy naive (no prior therapy allowed).
- Male or female 13 years of age or older (or 18 years of age or older according to local requirements).
- Female subjects must be of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including women who are post-menopausal) or of child-bearing potential with a negative blood pregnancy test at screen and who agree to use a proven barrier method of contraception (e.g. spermicide plus condom) during the study period. Hormonal contraceptives will not be considered sufficient forms of contraception for this study. All subjects participating in this study should be counselled on the practice of safe or safer sex.
- Able to understand and provide written informed consent to participate in this trial. Parental or guardian consent must also be obtained for subjects under the age of 18 years.
Who cannot join
- Prior history of having received antiretroviral therapy.
- An active HIV Associated Disease (Center for Disease Control Category C) within 28 days of study drug administration.
- Any sudden onset or sharp rise in a laboratory abnormality (including abnormally high laboratory values) at Screening that causes the investigator to have the opinion that the subject should not participate in the study of an investigational compound.
- Subjects with a laboratory result for estimated creatinine clearance less than 40 ml per minute within 28 days of study drug administration.
- Laboratory result for serum aminotransferase (AST, ALT) levels elevated greater than five to ten times (or more) the upper limit of the normal range within 28 days prior to study drug administration.
- Pregnant or lactating women.
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- History of clinically relevant pancreatitis or hepatitis within 6 months of study drug administration.
- Presence of any serious medical condition (e.g., diabetes, cardiac dysfunction, hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject.
- Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.
- History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject's participation in the study.
- Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or anticipated need for such treatment during the study.
- Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days of study drug administration.
- Treatment with any HIV vaccine within 3 months of study drug administration.
- Treatment with other selected medications within 28 days prior to receiving study medication or the anticipated need during the study.
- Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subject's ability to comply with the requirements of the study. Note: Subjects stabilized on methadone can be considered for participation.
- Treatment with other investigational drugs or therapies within 28 days prior to Day 1, or an anticipated need for such treatment during the study. Treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis.
- Other inclusion or exclusion criteria to be determined by the investigator and sponsor of the study.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States13 sites
GSK Clinical Trials Call Center
Altamonte Springs, Florida, 32701
GSK Clinical Trials Call Center
Atlanta, Georgia, 30339
GSK Clinical Trials Call Center
Denver, Colorado, 80220
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, 33308
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, 33316
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, 33334
GSK Clinical Trials Call Center
Greenville, North Carolina, 27858
GSK Clinical Trials Call Center
Little Rock, Arkansas, 72205
GSK Clinical Trials Call Center
Long Beach, California, 90813
GSK Clinical Trials Call Center
Newport Beach, California, 92663
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, 19107
GSK Clinical Trials Call Center
San Diego, California, 92101
GSK Clinical Trials Call Center
Washington D.C., District of Columbia, 20036
France3 sites
GSK Clinical Trials Call Center
Lyon, 69437
GSK Clinical Trials Call Center
Paris, 75475
GSK Clinical Trials Call Center
Paris, 75679
United Kingdom2 sites
GSK Clinical Trials Call Center
London, SE5 9RS
GSK Clinical Trials Call Center
Manchester, M8 6RL
About this study
Official title: A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects.
Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.
- Conditions
- HIV Infections
- Being tested
- fosamprenavir, COMBIVIR, ritonavir, TRIZIVIR
- Keywords
- fosamprenavir, ritonavir, COMBIVIR, TRIZIVIR, abacavir, lamivudine, zidovudine, HIV, protease inhibitors
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fosamprenavirDrug
COMBIVIRDrug
ritonavirDrug
TRIZIVIRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the overall short term tolerance of the regimens under investigation
Secondary outcomes (1)
Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2002 (estimated)
- Study startJan 2002
- Primary completionMay 2003
- Study completionMay 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT00043888
- Sponsor's protocol ID
- AZL30006
- Status last verified
- Feb 2013
- First submitted
- 14 Aug 2002
- Last updated
- 12 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects.
- ClinicalTrials.gov ID
- NCT00043888
- Acronym / sponsor ID
- AZL30006
- Conditions
- HIV Infections
- Keywords
- fosamprenavir, ritonavir, COMBIVIR, TRIZIVIR, abacavir, lamivudine, zidovudine, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 19 Aug 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.
Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL.
- Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter.
- Antiretroviral therapy naive (no prior therapy allowed).
- Male or female 13 years of age or older (or 18 years of age or older according to local requirements).
- Female subjects must be of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including women who are post-menopausal) or of child-bearing potential with a negative blood pregnancy test at screen and who agree to use a proven barrier method of contraception (e.g. spermicide plus condom) during the study period. Hormonal contraceptives will not be considered sufficient forms of contraception for this study. All subjects participating in this study should be counselled on the practice of safe or safer sex.
Key exclusion criteria (17 listed)
- Prior history of having received antiretroviral therapy.
- An active HIV Associated Disease (Center for Disease Control Category C) within 28 days of study drug administration.
- Any sudden onset or sharp rise in a laboratory abnormality (including abnormally high laboratory values) at Screening that causes the investigator to have the opinion that the subject should not participate in the study of an investigational compound.
- Subjects with a laboratory result for estimated creatinine clearance less than 40 ml per minute within 28 days of study drug administration.
- Laboratory result for serum aminotransferase (AST, ALT) levels elevated greater than five to ten times (or more) the upper limit of the normal range within 28 days prior to study drug administration.
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 |
|---|---|---|
| fosamprenavir | Drug | – |
| COMBIVIR | Drug | – |
| ritonavir | Drug | – |
| TRIZIVIR | Drug | – |
Primary outcome
To assess the overall short term tolerance of the regimens under investigation
1 secondary outcome
Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time.
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 12 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 study director
GlaxoSmithKline
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fosamprenavir, COMBIVIR and ritonavir in people with HIV Infections, run by GlaxoSmithKline at 18 sites in 3 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 6 inclusion and 17 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 12 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 18 sites in United States, France, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the overall short term tolerance of the regimens under investigation. 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 12 Feb 2013.