The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression a...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Topical and/or antifungal agents, except ketoconazole.
• • Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated.
• • Clinically indicated antibiotics, unless excluded.
• • Systemic corticosteroid use for \<21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided.
• • Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
• • Didanosine (ddI).
• • Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication.
• Patients must have:
• • A working diagnosis of HIV infection.
• • A CD4+ count between 200 and 500 cells/mm3.
• • Signed, informed parental consent if patient is less than 18.
• NOTE:
• • The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with any of the following conditions or symptoms are excluded:
• • Febrile illness with temperature \> 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry.
• Concurrent Medication:
• Excluded:
• • Non-nucleoside reverse transcriptase inhibitors.
• • Protease inhibitors except IDV.
• • Rifabutin and rifampin.
• • Ketoconazole.
• • Terfenadine, astemizole, cisapride, triazolam and midazolam.
• Patients with any of the following prior conditions are excluded:
• • History of prior saquinavir (SQV) therapy for more than 14 days.
• • History of any prior protease inhibitor therapy other than SQV.
• • History of serious opportunistic infection.