Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
Conditions
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Study Design
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TREATMENT
Interventions
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Abacavir sulfate
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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:
* 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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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Evanston Hosp / Clinical Pharmacology Unit
Evanston, Illinois, United States
Fenway Community Health Ctr / Research Dept
Boston, Massachusetts, United States
Albany Med College / Albany Med Ctr Hosp
Albany, New York, United States
Countries
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Other Identifiers
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CNAA1004
Identifier Type: -
Identifier Source: secondary_id
238G
Identifier Type: -
Identifier Source: org_study_id