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The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection

This study has been completed.

Sponsored by: Merck
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002179
  Purpose

To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below the limit of detection of the most sensitive validated assay (ultradirect assay) and (2) absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral mononuclear cells (PBMCs), and semen.

It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in:

  1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in 50% of patients who have undetectable viral RNA by the most sensitive validated assay available (ultradirect assay) for at least 48 weeks.
  2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25% of patients.
  3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay (i.e., negative) in at least 90% of patients by Week 16.
  4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy.

Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Zidovudine
Phase IV

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Lamivudine    Indinavir    Indinavir Sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Efficacy Study
Official Title:   A Multiclinic, Open Study to Evaluate the Ability of the Combination of Indinavir, Zidovudine and Lamivudine to Result in Sustained Suppression of HIV-1 in Asymptomatic HIV-1 Seropositive Patients

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   200

Detailed Description:

It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in:

  1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in 50% of patients who have undetectable viral RNA by the most sensitive validated assay available (ultradirect assay) for at least 48 weeks.
  2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25% of patients.
  3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay (i.e., negative) in at least 90% of patients by Week 16.
  4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy.

All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks. If there is no evidence of infectious virus, and patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay for at least 96 weeks, therapy is continued for an additional 24 weeks. However, during this additional 24 weeks of therapy patients may continue to receive this triple combination drug regimen or make changes to this drug regimen treatment by reducing their number of antiretroviral agents. After 120 weeks, if patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay, patients discontinue all antiretroviral therapy. However, if there is any evidence of infectious virus, as outlined above, patients do not discontinue therapy. Patients who develop detectable serum viral RNA following discontinuation of therapy are given the option to reinitiate therapy with the triple combination of indinavir, zidovudine and lamivudine. NOTE: Patients who develop an intolerance to zidovudine may use stavudine at doses per body weight at the direction of the investigator.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • HIV-1 seropositive status.
  • CD4 count >= 500 cells/mm3.
  • Serum viral RNA level > 1000 copies/ml.

Exclusion Criteria

Prior Medication:

Excluded:

Previous antiretroviral therapy.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002179

Locations
United States, Alabama
Univ of Alabama at Birmingham    
      Birmingham, Alabama, United States, 352942050
United States, California
LAC - USC Med Ctr    
      Los Angeles, California, United States, 90033
AIDS Community Research Consortium    
      Redwood City, California, United States, 94063
San Francisco Gen Hosp    
      San Francisco, California, United States, 94110
United States, Connecticut
Yale Univ School of Medicine / AIDS Program    
      New Haven, Connecticut, United States, 06510
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis    
      Chicago, Illinois, United States, 606123832
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21287
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)    
      Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med Ctr - East Campus    
      Boston, Massachusetts, United States, 02215
Brigham and Women's Hosp    
      Boston, Massachusetts, United States, 02115
Fenway Community Health Ctr    
      Boston, Massachusetts, United States, 02115
United States, New York
NYU Med Ctr    
      New York, New York, United States, 10016
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit    
      Stony Brook, New York, United States, 117948153
United States, Pennsylvania
Pitt Treatment Ctr    
      Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown Univ / Miriam Hosp    
      Providence, Rhode Island, United States, 02906
Canada, British Columbia
Saint Paul's Hosp    
      Vancouver, British Columbia, Canada
Canada, Quebec
Montreal Gen Hosp    
      Montreal, Quebec, Canada

Sponsors and Collaborators
Merck
  More Information


Study ID Numbers:   246G, MK-0639
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002179
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Semen  
Monocytes  
HIV-1  
Drug Therapy, Combination  
Zidovudine  
Lymph Nodes  
HIV Protease Inhibitors  
Lamivudine
Indinavir
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Indinavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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