HIV InfectionsNCT00002217
A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs
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 test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs. 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 greater than 50 cells/mm3.
- HIV RNA less than 50,000 copies/ml.
- No active AIDS (excluding CD4 count less than 200 cells/mm3).
- Ability to comply with dosing schedule and protocol evaluations.
- Prior Medication:
- Allowed:
- AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Active AIDS (not excluding CD4 count less than 200).
- Malabsorption syndrome affecting drug absorption.
- Serious medical condition that would compromise safety of the patient.
- Concurrent Medication:
Show all 14Show fewer
- Excluded:
- AZT or NNRTIs.
- More than 1 week treatment with any protease inhibitor.
- Enrollment in any other investigational drug protocol.
- Patients with the following prior conditions are excluded:
- History of clinically relevant pancreatitis or hepatitis within the past 6 months.
- Required:
- Antiretroviral therapy with either single or double 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: Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial
The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.
Read the detailed description
In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Lamivudine/Zidovudine, Abacavir sulfate, Amprenavir
- Keywords
- Drug Therapy, Combination, Patient Compliance, Anti-HIV Agents, abacavir
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine/ZidovudineDrug
Abacavir sulfateDrug
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- NCT00002217
- Sponsor's protocol ID
- 280D
- Other IDs
- UNAP 12, NZTA 4005
- Status last verified
- May 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Henry K, Shaeffer M, Ross L, Johnson M, Fisher R, Liao Q, Graham N. Response to Combivir and abacavir given bid to nucleoside experienced patients is not affected by the presence of the M184V mutation. 6th Conf Retro and Opportun Infect. 1999 Jan 31 - Feb 4 (abstract no 132)
Henry K, Wallace RJ, Bellman PC, Norris D, Fisher RL, Ross LL, Liao Q, Shaefer MS; TARGET Study Team. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis. 2001 Feb 15;183(4):571-8. doi: 10.1086/318527. Epub 2001 Jan 11.
PubMed 11170982
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
- Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial
- ClinicalTrials.gov ID
- NCT00002217
- Acronym / sponsor ID
- 280D
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Patient Compliance, 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 test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.
Detailed description
In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.
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 (8 listed)
- CD4 count greater than 50 cells/mm3.
- HIV RNA less than 50,000 copies/ml.
- No active AIDS (excluding CD4 count less than 200 cells/mm3).
- Ability to comply with dosing schedule and protocol evaluations.
- AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Key exclusion criteria (14 listed)
- Active AIDS (not excluding CD4 count less than 200).
- Malabsorption syndrome affecting drug absorption.
- Serious medical condition that would compromise safety of the patient.
- AZT or NNRTIs.
- More than 1 week treatment with any 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 |
|---|---|---|
| Lamivudine/Zidovudine | Drug | – |
| Abacavir sulfate | Drug | – |
| 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.
- BackgroundHenry K, Shaeffer M, Ross L, Johnson M, Fisher R, Liao Q, Graham N. Response to Combivir and abacavir given bid to nucleoside experienced patients is not affected by the presence of the M184V mutation. 6th Conf Retro and Opportun Infect. 1999 Jan 31 - Feb 4 (abstract no 132)
- Background: PubMed 11170982Henry K, Wallace RJ, Bellman PC, Norris D, Fisher RL, Ross LL, Liao Q, Shaefer MS; TARGET Study Team. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis. 2001 Feb 15;183(4):571-8. doi: 10.1086/318527. Epub 2001 Jan 11.
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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 8 inclusion and 14 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?
On the ClinicalTrials.gov record for NCT00002217, which also lists 2 linked publications.
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.