A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC… (NCT00002199) | Clinical Trial Compass
CompletedPhase 3
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
United States550 participants
Plain-language summary
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.
Who can participate
Age range16 Years
SexALL
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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 Trea…