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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002430
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine Not Applicable

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  (Clinical Trial)
Enrollment : 220 participants
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002430

  Hide Study Locations
United States, Alabama
Univ of Alabama School of Med
Montgomery, Alabama, United States, 36116
United States, California
Ocean View Internal Medicine
Long Beach, California, United States, 90803
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Tower ID Med Associates
Los Angeles, California, United States, 90048
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, United States, 90059
Robert Scott MD
Oakland, California, United States, 94609
AIDS Community Research Consortium
Redwood City, California, United States, 94063
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States, 94109
Pacific Horizons Med Group
San Francisco, California, United States, 94115
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
United States, Colorado
Denver Public Health Dept
Denver, Colorado, United States, 80204
United States, Connecticut
Blick Med Associates
Stamford, Connecticut, United States, 06901
United States, District of Columbia
Physicans Home Service
Washington, District of Columbia, United States, 20037
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
Harold Katner MD
Macon, Georgia, United States, 31202
United States, Idaho
Thomas Coffman MD
Boise, Idaho, United States, 83712
United States, Illinois
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
Northwestern Univ Med Ctr
Chicago, Illinois, United States, 60611
Univ of Illinois
Chicago, Illinois, United States, 60612
United States, Kentucky
Kentucky Clinical Research
Lexington, Kentucky, United States, 40504
United States, Louisiana
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States, 70112
United States, Maine
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, United States, 04102
United States, Maryland
Institute of Human Virology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
JSI Research and Training Institute
Boston, Massachusetts, United States, 02210
United States, New Jersey
Education & Research Building
Camden, New Jersey, United States, 08103
Newark, New Jersey, United States, 07103
Infectious Disease Specialists of NJ
Union, New Jersey, United States, 07083
United States, New York
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, United States, 112123198
Liberty Med Group
New York, New York, United States, 10016
James Jones MD
New York, New York, United States, 10019
Mount Sinai Med Ctr
New York, New York, United States, 10029
Community Health Network
Rochester, New York, United States, 14620
United States, North Carolina
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Oklahoma
Associates in Med and Mental Health
Tulsa, Oklahoma, United States, 74114
United States, Oregon
The Research and Education Group
Portland, Oregon, United States, 97210
Fanno Creek Clinic
Portland, Oregon, United States, 97219
United States, Pennsylvania
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Burnside Clinic
Columbia, South Carolina, United States, 29206
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37203
United States, Texas
Oak Lawn Physicians Group
Dallas, Texas, United States, 75219
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77555
United States, Washington
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Merck Sharp & Dohme Corp. Identifier: NCT00002430     History of Changes
Other Study ID Numbers: 246R
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors