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A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

This study has been completed.

Sponsored by: Merck
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002208
  Purpose

To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Phase III

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Lamivudine    Indinavir    Indinavir Sulfate    Stavudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Pharmacokinetics Study
Official Title:   A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

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

Estimated Enrollment:   400

Detailed Description:

Patients are randomized to 1 of 2 arms:

Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • HIV-1 seropositive status.
  • CD4 count greater than 100 cells/mm3.
  • Viral RNA above 10,000 copies/mL.
  • Consent from parent or guardian if less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior therapy with protease inhibitors.
  • Prior therapy with 3TC.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002208

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
Kaiser Med Ctr    
      San Francisco, California, United States, 94110
United States, Delaware
Wilmington Hosp / Med Ctr of Delaware    
      Wilmington, Delaware, United States, 19899
United States, District of Columbia
Georgetown Univ Med Ctr    
      Washington, District of Columbia, United States, 20007
United States, Georgia
AIDS Research Consortium of Atlanta    
      Atlanta, Georgia, United States, 30308
United States, Illinois
Cook County Hosp    
      Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21287
United States, Missouri
Washington Univ    
      St. Louis, Missouri, United States, 63108
United States, New York
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit    
      Stony Brook, New York, United States, 117948153
United States, Pennsylvania
Allegheny Univ Hosp    
      Philadelphia, Pennsylvania, United States, 19129
Pittsburgh Treatment Ctr / Univ of Pittsburgh    
      Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
Brown Univ / Miriam Hosp    
      Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Univ Med Ctr    
      Nashville, Tennessee, United States, 372321302
United States, Washington
Univ of Washington / AIDS Clinical Trial Unit    
      Seattle, Washington, United States, 98104

Sponsors and Collaborators
Merck
  More Information


Publications:

Study ID Numbers:   246M, 069-00
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002208
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1  
Drug Therapy, Combination  
Zidovudine  
HIV Protease Inhibitors  
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors

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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
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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