HIV InfectionsNCT00002216
A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment
A study testing Lamivudine/Zidovudine, Abacavir sulfate and 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 compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment. 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?
- Lamivudine/Zidovudine, Abacavir sulfate and 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- CD4 count > 50.
- HIV RNA > 5,000.
- No active AIDS (excluding CD4 count < 200).
- Ability to comply with dosing schedule and protocol evaluations.
- Prior Medication:
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- Allowed:
- 3TC or any protease inhibitor, if < 1 week of therapy.
- Other nucleoside analogs, if < 4 weeks of therapy.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Active AIDS (not including CD4 count < 200).
- Malabsorption syndrome affecting drug absorption.
- Concurrent Medication:
- Excluded:
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- Enrollment in any other investigational drug protocol.
- Prior Medication:
- Excluded:
- Non-nucleoside reverse transcriptase inhibitors.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients.
The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.
Read the detailed description
In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens:
Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.
- Conditions
- HIV Infections
- Being tested
- Lamivudine/Zidovudine, Abacavir sulfate, Amprenavir, Nelfinavir mesylate
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine/ZidovudineDrug
Abacavir sulfateDrug
AmprenavirDrug
Nelfinavir mesylateDrug
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
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002216
- Sponsor's protocol ID
- 280C
- Other IDs
- UNAP 11, NZTA 4002
- Status last verified
- May 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
- A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients.
- ClinicalTrials.gov ID
- NCT00002216
- Acronym / sponsor ID
- 280C
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
- 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 compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.
Detailed description
In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens:
Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.
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 (9 listed)
- CD4 count > 50.
- HIV RNA > 5,000.
- No active AIDS (excluding CD4 count < 200).
- Ability to comply with dosing schedule and protocol evaluations.
- 3TC or any protease inhibitor, if < 1 week of therapy.
Key exclusion criteria (10 listed)
- Active AIDS (not including CD4 count < 200).
- Malabsorption syndrome affecting drug absorption.
- Enrollment in any other investigational drug protocol.
- Non-nucleoside reverse transcriptase inhibitors.
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 |
|---|---|---|
| Lamivudine/Zidovudine | Drug | – |
| Abacavir sulfate | Drug | – |
| Amprenavir | Drug | – |
| Nelfinavir mesylate | 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 Lamivudine/Zidovudine, Abacavir sulfate and 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 9 inclusion and 10 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.