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.
2 other identifiers
interventional
550
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (1)
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Related Publications (1)
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; CNAAB3005 International Study Team. 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. doi: 10.1001/jama.285.9.1155.
PMID: 11231744BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-11