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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002406
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
  Purpose

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 Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: 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 NLM:


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

Estimated Enrollment: 350
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.

  Eligibility

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

Inclusion Criteria

Patients must have:

  • Documented HIV-1 seropositive status.
  • CD4 count greater than 100 cells/mm3.
  • Parental consent for patients under 18.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002406

  Hide Study Locations
Locations
United States, Alabama
1917 Research Clinic
Birmingham, Alabama, United States, 35294
United States, California
Tower ID Med Associates
Los Angeles, California, United States, 90048
Kaiser Permanente / Infectious Disease
Los Angeles, California, United States, 90027
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
Rush Presbyterian St Lukes Med Ctr
Chicago, Illinois, United States, 60612
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
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
CRIA
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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002406     History of Changes
Other Study ID Numbers: 246P, MK-0639
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Dose-Response Relationship, Drug
HIV Protease Inhibitors
Indinavir
RNA, Viral
Reverse Transcriptase Inhibitors

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

ClinicalTrials.gov processed this record on October 22, 2014