A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.

Key facts

Study ID

NCT00002440

Run by

Glaxo Wellcome

People needed

80

Last updated by the study team

2005-06-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• 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.

You may not qualify if…

• Co-existing Condition:
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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