HIV InfectionsPhase 3NCT00002245
A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients
A Phase 3 study testing Abacavir sulfate, Amprenavir and Lamivudine in people with HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in HIV-infected patients who have received little or no previous anti-HIV drug therapy. 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?
- Abacavir sulfate, Amprenavir and Lamivudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have very little or no anti-HIV drug experience (see below for details) and have never taken ABC.
- Have a CD4 count greater than or equal to 200 cells/mm3 within 30 days prior to study entry.
- Have a viral load (level of HIV in the blood) greater than 500 copies/ml within 30 days prior to study entry.
- Agree to use effective methods of birth control during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have taken both 3TC and stavudine (d4T).
- Have taken a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) for more than 7 days.
- Have taken a PI within 60 days of study entry.
- Have a history of diabetes.
- Have a history of untreated gonad or thyroid disorder.
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- Have a stomach or intestinal disorder which may affect the way the body absorbs the study drugs, or which may make them unable to take medications by mouth.
- Have received chemotherapy or radiation within 4 weeks prior to entry, or if they will need either of these during the study period.
- Have lost or gained a significant amount of weight (greater than 5%) within the past 2 months.
- Have a serious medical condition, such as heart disease.
- Are allergic to any of the study drugs.
- Have been treated for an infection or other medical illness within 14 days prior to study entry.
- Have had a fever (over 38.5 degrees Celsius) for any 7 days or chronic diarrhea (more than 3 liquid stools per day for 15 days) within 30 days prior to study entry.
- Have an AIDS-related cancer (other than Kaposi's sarcoma).
- Abuse alcohol or drugs.
- Have received certain medications.
- Are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033
About this study
Official title: Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection
The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in HIV-infected patients who have received little or no previous anti-HIV drug therapy.
Read the detailed description
This single-site study uses an open-label, single-arm design to evaluate the effects of APV, a protease inhibitor (PI), plus concurrent nucleoside reverse transcriptase inhibitors (NRTIs) ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic, HIV-1 infected patients initiating antiretroviral therapy. Treatment duration is 24 weeks, and patients serve as their own controls. The combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor (less than 400 copies/ml) and Ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Amprenavir, Lamivudine
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Carbohydrates, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipids, Insulin Resistance, abacavir
- Medical subject headings
- HIV Infections, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfateDrug
AmprenavirDrug
LamivudineDrug
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)
- Study startApr 1999
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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- M Dube, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002245
- Sponsor's protocol ID
- 264L
- Other IDs
- COL30309
- Status last verified
- Aug 2000
- 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
- Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT00002245
- Acronym / sponsor ID
- 264L
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Carbohydrates, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- 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 evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in HIV-infected patients who have received little or no previous anti-HIV drug therapy.
Detailed description
This single-site study uses an open-label, single-arm design to evaluate the effects of APV, a protease inhibitor (PI), plus concurrent nucleoside reverse transcriptase inhibitors (NRTIs) ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic, HIV-1 infected patients initiating antiretroviral therapy. Treatment duration is 24 weeks, and patients serve as their own controls. The combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor (less than 400 copies/ml) and Ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Are at least 18 years old.
- Have very little or no anti-HIV drug experience (see below for details) and have never taken ABC.
- Have a CD4 count greater than or equal to 200 cells/mm3 within 30 days prior to study entry.
- Have a viral load (level of HIV in the blood) greater than 500 copies/ml within 30 days prior to study entry.
Key exclusion criteria (17 listed)
- Have taken both 3TC and stavudine (d4T).
- Have taken a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) for more than 7 days.
- Have taken a PI within 60 days of study entry.
- Have a history of diabetes.
- Have a history of untreated gonad or thyroid disorder.
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 |
|---|---|---|
| Abacavir sulfate | Drug | – |
| Amprenavir | Drug | – |
| Lamivudine | 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.
M Dube study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abacavir sulfate, Amprenavir and Lamivudine 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 7 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 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.
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.
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.