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.

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002199
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002199 on ClinicalTrials.gov Archive Site
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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.
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.

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Lamivudine/Zidovudine
  • Drug: Abacavir sulfate
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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. Erratum in: JAMA 2001 Jun 13;285(22):2858.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
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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 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.

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002199
238K, CNAA/B3005
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
November 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP