A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals

The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Indinavir sulfate; Drug: Lamivudine; Drug: Stavudine; Drug: Nelfinavir mesylate

Detailed Description

Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

• Study Type: Interventional
• Enrollment: 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36116
      • Univ of Alabama School of Med
  • California
    • Long Beach, California, United States, 90803
      • Ocean View Internal Medicine
    • Los Angeles, California, United States, 90027
      • AIDS Healthcare Foundation
    • Los Angeles, California, United States, 90059
      • Oasis Clinic / King Drew Med Ctr
    • Los Angeles, California, United States, 90048
      • Tower ID Med Associates
    • Oakland, California, United States, 94609
      • Robert Scott MD
    • Redwood City, California, United States, 94063
      • AIDS Community Research Consortium
    • San Francisco, California, United States, 94115
      • Pacific Horizons Med Group
    • San Francisco, California, United States, 94118
      • Kaiser Foundation Hospital
    • San Francisco, California, United States, 94109
      • Saint Francis Mem Hosp / HIV Care Unit
    • Torrance, California, United States, 90502
      • Harbor - UCLA Med Ctr
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Public Health Dept
  • Connecticut
    • Stamford, Connecticut, United States, 06901
      • Blick Med Associates
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Physicans Home Service
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • IDC Research Initiative
    • Miami, Florida, United States, 33136
      • Univ of Miami School of Medicine
    • Tampa, Florida, United States, 33602
      • Hillsborough County Health Dept
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory Univ
    • Macon, Georgia, United States, 31202
      • Harold Katner MD
  • Idaho
    • Boise, Idaho, United States, 83712
      • Thomas Coffman MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ Med Ctr
    • Chicago, Illinois, United States, 60610
      • Chicago Ctr for Clinical Research
    • Chicago, Illinois, United States, 60612
      • Univ of Illinois
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Kentucky Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State Univ Med Ctr / Tulane Med School
  • Maine
    • Portland, Maine, United States, 04102
      • AIDS Consultation Service / Maine Med Ctr
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Institute of Human Virology
  • Massachusetts
    • Boston, Massachusetts, United States, 02210
      • JSI Research and Training Institute
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Education & Research Building
    • Newark, New Jersey, United States, 07103
      • NJCRI
    • Union, New Jersey, United States, 07083
      • Infectious Disease Specialists of NJ
  • New York
    • Brooklyn, New York, United States, 112123198
      • Brookdale Univ Hosp and Med Ctr
    • New York, New York, United States, 10029
      • Mount Sinai Med Ctr
    • New York, New York, United States, 10019
      • James Jones MD
    • New York, New York, United States, 10016
      • Liberty Med Group
    • Rochester, New York, United States, 14620
      • Community Health Network
  • North Carolina
    • Winston Salem, North Carolina, United States, 27157
      • Wake Forest Univ School of Medicine
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74114
      • Associates in Med and Mental Health
  • Oregon
    • Portland, Oregon, United States, 97219
      • Fanno Creek Clinic
    • Portland, Oregon, United States, 97210
      • The Research and Education Group
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Anderson Clinical Research / Inc
  • South Carolina
    • Columbia, South Carolina, United States, 29206
      • Burnside Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt Univ Med Ctr
  • Texas
    • Dallas, Texas, United States, 75219
      • Oak Lawn Physicians Group
    • Galveston, Texas, United States, 77555
      • Univ TX Galveston Med Branch
  • Washington
    • Tacoma, Washington, United States, 98405
      • Infections Ltd / Physicians Med Ctr

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

You may be eligible for this study if you:

• Are HIV positive.
• Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
• Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
• Have a normal chest X-ray.
• Have never taken protease inhibitors or 3TC.
• Are 16 years of age or older.
• Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).

Exclusion Criteria

You will not be eligible for this study if you:

• Have an active opportunistic (AIDS-related) infection or cancer.
• Have certain types of Kaposi's sarcoma.
• Have hepatitis.
• Have chronic diarrhea.
• Have a history of certain medical conditions.
• Are allergic to any of the study medications.
• Are taking certain medications.
• Are pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

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: February 1, 2000

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Lamivudine; HIV Protease Inhibitors; Nelfinavir; Indinavir
• 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; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Lamivudine; Stavudine; Indinavir; Nelfinavir
• Other Study ID Numbers: 246R; 079-02; CRX454