HIV InfectionsNCT00002417
A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications
A study testing Amprenavir in people with HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give the protease inhibitor (PI) amprenavir (APV) to patients with fat production and distribution problems associated with other PIs. Protease inhibitors are very effective in treating HIV-1 disease. 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?
- Amprenavir
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Patients must have:
- Documented HIV-1 infection.
- Two consecutive (at least 4 weeks apart) screening HIV-1 plasma RNA levels less than or equal to 10,000 copies/ml prior to open-label drug administration.
- Hyperlipidemia with or without lipodystrophy (Grade 1-4 toxicity for triglycerides or total cholesterol), be intolerant to standard protease inhibitor therapy and, in the judgment of the physician, be unable to construct a viable treatment regimen without APV.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Renal failure requiring dialysis.
- Hepatic failure.
- Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction which, in the opinion of the investigator, would compromise the safety of the patient.
- Malabsorption syndrome or other gastrointestinal dysfunction, which might interfere with drug absorption or render the patient unable to take oral medication.
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- Concurrent Treatment:
- Excluded:
- Concomitant use of another protease inhibitor.
- Patients with the following prior condition are excluded:
- Clinically relevant history of pancreatitis or hepatitis within the last 6 months.
- Prior Treatment:
- Excluded:
- Previous treatment with APV.
- Risk Behavior:
- Excluded:
- Patients currently using alcohol or illicit drugs which, in the investigator's opinion, may interfere with the patient's ability to comply with the requirements of the study.
- Included:
- Prior treatment with at least one protease inhibitor.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
About this study
Official title: An Open-Label Study to Evaluate the Safety and Tolerance of Amprenavir (141W94) Combination Therapy in Protease Inhibitor Experienced Subjects Who Are Intolerant (Hyperlipidemia With or Without Lipodystrophy) But Not Failing Their Current Protease Inhibitor Therapy
The purpose of this study is to see if it is safe and effective to give the protease inhibitor (PI) amprenavir (APV) to patients with fat production and distribution problems associated with other PIs.
Protease inhibitors are very effective in treating HIV-1 disease. However, patients who take these drugs often have problems, such as hyperlipidemia (an increased level of fat in the blood) and lipodystrophy (problems with the way fat is produced and distributed in the body). Doctors do not know exactly how PIs are related to these problems. APV has been shown to be safe and effective in lowering plasma viral loads (level of HIV in the blood). APV may be useful for patients who develop complications associated with other PIs.
Read the detailed description
Protease inhibitors are highly efficacious in the treatment of HIV-1 disease. Current drugs, however, are associated with a high incidence of adverse effects as well as metabolic complications such as lipodystrophy and hyperlipidemia. At the same time, though, a causal relationship linking these complications to the use of protease inhibitors remains to be established. Studies have shown APV to be well tolerated and effective in reducing plasma HIV-1 RNA levels. The safety profile of APV suggests it may offer therapeutic potential in subjects developing intolerance to other protease inhibitors.
Patients receive open-label APV plus at least 2 other antiretroviral drugs. Fasting blood samples and patient medication adherence questionnaires are collected at Weeks 12 and 24. Bodily assessments are collected at Day 1 and Weeks 12 and 24. Hematology, serum chemistry, plasma HIV-1 viral load determination and CD4+ cell count measurements are collected at pre-entry and every 12 weeks for the duration of the study.
- Conditions
- HIV Infections
- Being tested
- Amprenavir
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, VX 478, Lipodystrophy, Hyperlipidemia
- Medical subject headings
- HIV Infections, Lipodystrophy, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmprenavirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
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.
- 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 N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002417
- Sponsor's protocol ID
- 264J
- Other IDs
- PRO30012
- Status last verified
- Apr 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety and Tolerance of Amprenavir (141W94) Combination Therapy in Protease Inhibitor Experienced Subjects Who Are Intolerant (Hyperlipidemia With or Without Lipodystrophy) But Not Failing Their Current Protease Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT00002417
- Acronym / sponsor ID
- 264J
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, VX 478, Lipodystrophy, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to see if it is safe and effective to give the protease inhibitor (PI) amprenavir (APV) to patients with fat production and distribution problems associated with other PIs.
Protease inhibitors are very effective in treating HIV-1 disease. However, patients who take these drugs often have problems, such as hyperlipidemia (an increased level of fat in the blood) and lipodystrophy (problems with the way fat is produced and distributed in the body). Doctors do not know exactly how PIs are related to these problems. APV has been shown to be safe and effective in lowering plasma viral loads (level of HIV in the blood). APV may be useful for patients who develop complications associated with other PIs.
Detailed description
Protease inhibitors are highly efficacious in the treatment of HIV-1 disease. Current drugs, however, are associated with a high incidence of adverse effects as well as metabolic complications such as lipodystrophy and hyperlipidemia. At the same time, though, a causal relationship linking these complications to the use of protease inhibitors remains to be established. Studies have shown APV to be well tolerated and effective in reducing plasma HIV-1 RNA levels. The safety profile of APV suggests it may offer therapeutic potential in subjects developing intolerance to other protease inhibitors.
Patients receive open-label APV plus at least 2 other antiretroviral drugs. Fasting blood samples and patient medication adherence questionnaires are collected at Weeks 12 and 24. Bodily assessments are collected at Day 1 and Weeks 12 and 24. Hematology, serum chemistry, plasma HIV-1 viral load determination and CD4+ cell count measurements are collected at pre-entry and every 12 weeks for the duration of the study.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Documented HIV-1 infection.
- Two consecutive (at least 4 weeks apart) screening HIV-1 plasma RNA levels less than or equal to 10,000 copies/ml prior to open-label drug administration.
- Hyperlipidemia with or without lipodystrophy (Grade 1-4 toxicity for triglycerides or total cholesterol), be intolerant to standard protease inhibitor therapy and, in the judgment of the physician, be unable to construct a viable treatment regimen without APV.
Key exclusion criteria (19 listed)
- Renal failure requiring dialysis.
- Hepatic failure.
- Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction which, in the opinion of the investigator, would compromise the safety of the patient.
- Malabsorption syndrome or other gastrointestinal dysfunction, which might interfere with drug absorption or render the patient unable to take oral medication.
- Concomitant use of another protease inhibitor.
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 |
|---|---|---|
| Amprenavir | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amprenavir in people with HIV Infections, run by Glaxo Wellcome at 1 site 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 19 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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.
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 24 Jun 2005.