Expired Study
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Boston, Massachusetts 02215


Purpose:

To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.


Study summary:

In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA >= 400 copies/ml (by PCR on two occasions >= 1 week and < 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: GM-CSF, G-CSF, and erythropoietin. Concurrent Treatment: Allowed: Local treatment for Kaposi's sarcoma. 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 positive HIV-1 blood culture. - CD4+ cell count >= 100 cells/mm3 within 14 days prior to study drug administration. - HIV-1 RNA >= 10,000 copies/ml within 14 days prior to study drug administration. - No active diagnosis of AIDS according to the 1993 Centers for Disease Control (CDC) AIDS surveillance definition (excluding CD4+ cell counts < 200 cells/mm3). - Signed, informed consent from parent or legal guardian for patients under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption. - Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that would compromise the safety of the patient. Concurrent Medication: Excluded: - Cytotoxic chemotherapeutic agents. - Agents with documented anti-HIV-1 activity in vitro. - Foscarnet. - Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, or interferons. - Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine. Concurrent Treatment: Excluded: - Radiation therapy. - Other investigational treatments. NOTE: - Treatments available through treatment IND or other expanded access programs are the exception and evaluated individually. Patients with the following prior conditions are excluded: History of relevant pancreatitis or hepatitis in the last 6 months. Prior Medication: Excluded: - Cytotoxic chemotherapeutic agents within 30 days of study drug administration. - Prior antiretroviral therapy. - HIV vaccine dose within 90 days of study drug administration. - Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study entry. Prior Treatment: Excluded: Radiation therapy within 30 days of study drug administration. Current alcohol or illicit drug use that may interfere with patient compliance.


NCT ID:

NCT00002199


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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