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.
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Lamivudine/Zidovudine (Drug); Abacavir sulfate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
Official title: 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.
Study design: Treatment, Parallel Assignment, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02215, United States
Additional Information
Related publications: Staszewski S, Keiser P, Montaner J, Raffi F, Gathe J, Brotas V, Hicks C, Hammer SM, Cooper D, Johnson M, Tortell S, Cutrell A, Thorborn D, Isaacs R, Hetherington S, Steel H, Spreen W. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial. JAMA. 2001 Mar 7;285(9):1155-63.
Last updated: June 23, 2005
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