A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
NCT ID: NCT00002440
Last Updated: 2005-06-24
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
PHASE2
80 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Ritonavir
Abacavir sulfate
Amprenavir
Nelfinavir mesylate
Saquinavir
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Local treatment for Kaposi's sarcoma.
* GM-CSF, G-CSF or erythropoietin.
Patients must have:
* HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.
* CD4+ cell count \>= 100 cells/mm3 within 14 days of study drug administration.
* HIV-1 RNA \>= 5,000 copies/ml within 14 days of study drug administration.
* No active or ongoing AIDS-defining opportunistic infection or disease.
* Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
Prior Medication:
Allowed:
Local treatment for Kaposi's sarcoma.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.
* Life-threatening infection or other serious medical condition that may compromise a patient's safety.
Concurrent Medication:
Excluded:
* Other investigational agents. NOTE:
* Those available through Treatment IND or expanded access programs are evaluated individually.
* Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).
* Agents with documented anti-HIV activity in vitro.
* Foscarnet.
* Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons.
* Antioxidants.
Concurrent Treatment:
Excluded:
Radiation therapy within the first 24 weeks of study.
Patients with the following prior conditions are excluded:
* History of clinically relevant pancreatitis or hepatitis within the last 6 months.
* Participation in an investigational HIV-1 vaccine trial.
Prior Medication:
Excluded:
* Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy.
* Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
* HIV-1 vaccine dose within the 3 months prior to study drug administration.
* Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration.
Prior Treatment:
Excluded:
Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.
16 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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UCSD Treatment Ctr
San Diego, California, United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States
NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial
New York, New York, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
Case Western Reserve Univ / AIDS Clinical Trials Unit
Cleveland, Ohio, United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Countries
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Other Identifiers
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CNAA2004
Identifier Type: -
Identifier Source: secondary_id
238J
Identifier Type: -
Identifier Source: org_study_id