HIV InfectionsPhase 2NCT00002364
A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
A Phase 2 study testing Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 8 sites in United States.
Trial summary
To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs. 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?
- Abacavir sulfate
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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:
- CD4+ cell count >= 100 /mm3.
- Plasma HIV RNA >= 30,000 copies/ml.
- Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria.
- Parent or legal guardian to sign written, informed consent for patients under the age of 18.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
- For this study, a CD4+ cell count <= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
- Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
- Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.
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- Concurrent Medication:
- Excluded:
- Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
- Patients receiving other investigational drugs.
- Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro.
- Treatment with immunomodulators.
- Patients on methadone.
- Concurrent Treatment:
- Excluded:
- Treatment with radiation therapy within the 24 weeks of the study. NOTE:
- Localized radiation therapy may be permitted following consultation with the sponsor.
- Patients with any of the following prior conditions are excluded:
- Subjects with a history of lymphoma.
- Subjects with a history of clinically apparent pancreatitis or hepatitis within the last 6 months.
- Prior Medication:
- Excluded:
- Treatment with any antiretroviral therapy with NRTIs (alone or in combination) other than those defined for each treatment group.
- Treatment with any non-nucleoside RT inhibitors or protease inhibitors.
- Treatment with cytotoxic chemotherapeutic agents within 1 month prior to study entry.
- Investigational HIV vaccine within the past 3 months.
- Immunomodulating agents such as systematic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.
- Prior Treatment:
- Excluded:
- Treatment with radiation therapy within 1 month of entry.
- Risk Behavior:
- Excluded:
- Patients with current alcohol or illicit drug use that, in the opinion of the principal investigator, may interfere with the patient's ability to comply with the study protocol.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
North Broward Hosp District
Fort Lauderdale, Florida, 33316
Marin County Specialty Clinic
Greenbrae, California, 94904
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
Kraus Med Partners
Los Angeles, California, 90036
Beth Israel Med Ctr
New York, New York, 10003
ViRx Inc
San Francisco, California, 94109
About this study
Official title: An Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients
To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs.
Read the detailed description
Patients will all receive oral doses of 1592U89 in combination with protocol specific current antiretroviral therapy. The treatment groups will be assigned based on each subject's previous NRTI experience.
The study medication is self administered and all evaluations will be performed on an outpatient basis. Patients will be seen at day 0 and weeks 2, 4, 12, 16, 20 and 24.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfateDrug
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 2
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002364
- Sponsor's protocol ID
- 238C
- Other IDs
- CNAA 2003
- Status last verified
- Apr 1997
- 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 Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients
- ClinicalTrials.gov ID
- NCT00002364
- Acronym / sponsor ID
- 238C
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- 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.
To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs.
Detailed description
Patients will all receive oral doses of 1592U89 in combination with protocol specific current antiretroviral therapy. The treatment groups will be assigned based on each subject's previous NRTI experience.
The study medication is self administered and all evaluations will be performed on an outpatient basis. Patients will be seen at day 0 and weeks 2, 4, 12, 16, 20 and 24.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- CD4+ cell count >= 100 /mm3.
- Plasma HIV RNA >= 30,000 copies/ml.
- Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria.
- Parent or legal guardian to sign written, informed consent for patients under the age of 18.
Key exclusion criteria (33 listed)
- Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
- For this study, a CD4+ cell count <= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
- Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
- Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.
- Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
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 | – |
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 8 sites 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 5 inclusion and 33 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 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.