A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)

The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Indinavir sulfate

Detailed Description

In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:

Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

• Study Type: Interventional
• Enrollment: 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • 1917 Research Clinic
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente / Infectious Disease
    • Los Angeles, California, United States, 90048
      • Tower ID Med Associates
    • Sacramento, California, United States, 95814
      • Ctr for AIDS Research / Education and Service (CARES)
    • San Francisco, California, United States, 94110
      • San Francisco Gen Hosp / UCSF AIDS Program
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • HIV Clinical Research
    • Miami, Florida, United States, 33136
      • Univ of Miami School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium of Atlanta
    • Atlanta, Georgia, United States, 30308
      • Ponce de Leon Ctr
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ Med School
    • Chicago, Illinois, United States, 60612
      • Rush Presbyterian St Lukes Med Ctr
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Natl Naval Med Ctr / Special Immunology Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hosp
    • Boston, Massachusetts, United States, 02118
      • Boston Med Ctr / Clinical Research Office
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Univ Health Ctr 7D
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Kansas City Free Health Clinic
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Education & Research Building
    • Voorhees, New Jersey, United States, 08043
      • Garden State Infectious Diseases / E I P Kennedy Health Sys
  • New York
    • Albany, New York, United States, 12208
      • Albany Med College / Div of HIV Medicine
    • Brooklyn, New York, United States, 11203
      • SUNY / Health Science Ctr at Brooklyn
    • Flushing, New York, United States, 11355
      • New York Hosp of Queens / AIDS Ctr
    • New York, New York, United States, 10001
      • CRIA
    • New York, New York, United States, 10011
      • St Vincents Hosp and Med Ctr / Div of HIV Med
    • New York, New York, United States, 10016
      • Anderson Clinical Research
  • Ohio
    • Akron, Ohio, United States, 44304
      • Akron City Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Univ
    • Pittsburgh, Pennsylvania, United States, 15213
      • Anderson Clinical Research
  • Texas
    • Houston, Texas, United States, 77098
      • Houston Clinical Research Network / Southhampton Med Group
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Univ of Utah School Of Medicine / Div of Infec Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Patients must have:

• Documented HIV-1 seropositive status.
• CD4 count greater than 100 cells/mm3.
• Parental consent for patients under 18.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: June 1, 1999

More Information

Terms related to this study

• Keywords: Reverse Transcriptase Inhibitors; HIV-1; RNA, Viral; HIV Protease Inhibitors; Indinavir; Dose-Response Relationship, Drug
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Indinavir
• Other Study ID Numbers: 246P; MK-0639