HIV InfectionsPhase 1NCT00002388
A Study of 1592U89 in HIV-Infected Patients
A Phase 1 study testing Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 3 sites in United States.
Trial summary
The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood). 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
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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
- Concurrent Medication:
- Allowed:
- Prophylaxis for opportunistic infections.
- Patients must have:
- HIV-1 infection.
- CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
- No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions and symptoms are excluded:
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
- Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.
- Concurrent Medication:
- Excluded:
Show all 23Show fewer
- Immunomodulating agents.
- Chemotherapeutic agents.
- Antiretroviral therapy. NOTE:
- Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
- History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
- Prior Medication:
- Excluded:
- Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
- Antiretroviral therapy within 2 weeks prior to administration of study drugs.
- Prior Treatment:
- Excluded:
- Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Albany Med College / Albany Med Ctr Hosp
Albany, New York, 12208
Fenway Community Health Ctr / Research Dept
Boston, Massachusetts, 02115
Evanston Hosp / Clinical Pharmacology Unit
Evanston, Illinois, 60201
About this study
Official title: A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects
The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).
Read the detailed description
Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.
On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate
- Keywords
- HIV-1, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Medical subject headings
- HIV Infections
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 1
- Primary purpose
- Treatment
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002388
- Sponsor's protocol ID
- 238G
- Other IDs
- CNAA1004
- Status last verified
- Nov 1998
- 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 Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT00002388
- Acronym / sponsor ID
- 238G
- Conditions
- HIV Infections
- Keywords
- HIV-1, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 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.
The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).
Detailed description
Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.
On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Prophylaxis for opportunistic infections.
- HIV-1 infection.
- CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
- No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.
Key exclusion criteria (23 listed)
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
- Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.
- Immunomodulating agents.
- Chemotherapeutic agents.
- Antiretroviral therapy. NOTE:
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 3 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 7 inclusion and 23 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 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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; AzTrials last refreshed its copy on 7 Nov 2026.