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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Indinavir sulfate  Drug: Ritonavir  Drug: Abacavir sulfate  Drug: Amprenavir  Drug: Nelfinavir mesylate  Drug: Saquinavir	Phase II

Further Study Details: 

Expected Total Enrollment:  80

In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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. Prior Treatment: Excluded: Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.

California
      UCSD Treatment Ctr, San Diego,  California,  921036329,  United States
Connecticut
      Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit, New Haven,  Connecticut,  065102483,  United States
Missouri
      Kansas City AIDS Research Consortium, Kansas City,  Missouri,  64111,  United States
New York
      NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial, New York,  New York,  10016,  United States
North Carolina
      Carolinas Med Ctr, Charlotte,  North Carolina,  28232,  United States
Ohio
      Case Western Reserve Univ / AIDS Clinical Trials Unit, Cleveland,  Ohio,  44106,  United States
Pennsylvania
      Univ of Pittsburgh Med Ctr, Pittsburgh,  Pennsylvania,  15213,  United States
Tennessee
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  372321302,  United States

Study ID Numbers:  238J; CNAA2004
Record last reviewed:  November 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002440
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08