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)
2 other identifiers
interventional
350
1 country
29
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Documented HIV-1 seropositive status.
- CD4 count greater than 100 cells/mm3.
- Parental consent for patients under 18.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
1917 Research Clinic
Birmingham, Alabama, 35294, United States
Kaiser Permanente / Infectious Disease
Los Angeles, California, 90027, United States
Tower ID Med Associates
Los Angeles, California, 90048, United States
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, 95814, United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110, United States
HIV Clinical Research
Fort Lauderdale, Florida, 33316, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Ponce de Leon Ctr
Atlanta, Georgia, 30308, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian St Lukes Med Ctr
Chicago, Illinois, 60612, United States
Natl Naval Med Ctr / Special Immunology Clinic
Bethesda, Maryland, 20889, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115, United States
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, 02118, United States
Univ Health Ctr 7D
Detroit, Michigan, 48201, United States
Kansas City Free Health Clinic
Kansas City, Missouri, 64111, United States
Education & Research Building
Camden, New Jersey, 08103, United States
Garden State Infectious Diseases / E I P Kennedy Health Sys
Voorhees Township, New Jersey, 08043, United States
Albany Med College / Div of HIV Medicine
Albany, New York, 12208, United States
SUNY / Health Science Ctr at Brooklyn
Brooklyn, New York, 11203, United States
New York Hosp of Queens / AIDS Ctr
Flushing, New York, 11355, United States
CRIA
New York, New York, 10001, United States
St Vincents Hosp and Med Ctr / Div of HIV Med
New York, New York, 10011, United States
Anderson Clinical Research
New York, New York, 10016, United States
Akron City Hospital
Akron, Ohio, 44304, United States
Thomas Jefferson Univ
Philadelphia, Pennsylvania, 19107, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213, United States
Houston Clinical Research Network / Southhampton Med Group
Houston, Texas, 77098, United States
Univ of Utah School Of Medicine / Div of Infec Disease
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-06