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

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: NCT00002406
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 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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Indinavir sulfate Phase 3

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  (Clinical Trial)
Enrollment : 350 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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

Inclusion Criteria

Patients must have:

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

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): NCT00002406

  Hide Study Locations
United States, Alabama
1917 Research Clinic
Birmingham, Alabama, United States, 35294
United States, California
Kaiser Permanente / Infectious Disease
Los Angeles, California, United States, 90027
Tower ID Med Associates
Los Angeles, California, United States, 90048
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, United States, 95814
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, United States, 94110
United States, Florida
HIV Clinical Research
Fort Lauderdale, Florida, United States, 33316
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Ponce de Leon Ctr
Atlanta, Georgia, United States, 30308
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian St Lukes Med Ctr
Chicago, Illinois, United States, 60612
United States, Maryland
Natl Naval Med Ctr / Special Immunology Clinic
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02115
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, United States, 02118
United States, Michigan
Univ Health Ctr 7D
Detroit, Michigan, United States, 48201
United States, Missouri
Kansas City Free Health Clinic
Kansas City, Missouri, United States, 64111
United States, New Jersey
Education & Research Building
Camden, New Jersey, United States, 08103
Garden State Infectious Diseases / E I P Kennedy Health Sys
Voorhees, New Jersey, United States, 08043
United States, New York
Albany Med College / Div of HIV Medicine
Albany, New York, United States, 12208
SUNY / Health Science Ctr at Brooklyn
Brooklyn, New York, United States, 11203
New York Hosp of Queens / AIDS Ctr
Flushing, New York, United States, 11355
New York, New York, United States, 10001
St Vincents Hosp and Med Ctr / Div of HIV Med
New York, New York, United States, 10011
Anderson Clinical Research
New York, New York, United States, 10016
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
United States, Pennsylvania
Thomas Jefferson Univ
Philadelphia, Pennsylvania, United States, 19107
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Houston Clinical Research Network / Southhampton Med Group
Houston, Texas, United States, 77098
United States, Utah
Univ of Utah School Of Medicine / Div of Infec Disease
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Merck Sharp & Dohme Corp. Identifier: NCT00002406     History of Changes
Other Study ID Numbers: 246P
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Drug
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors

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
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents