The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
A Multicenter, Open-Label, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention
3 other identifiers
interventional
100
1 country
40
Brief Summary
The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
40 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
April 7, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2001
April 7, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are 18 years of age or older.
- Have a CD4 cell count of at least 50 cells/mm3.
- Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml.
- Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart.
- Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks.
- Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment.
- Are naive to at least one of the selected NRTIs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Pacific Oaks Research
Beverly Hills, California, 90211, United States
Ocean View Internal Medicine
Long Beach, California, 90803, United States
Bisher Akil
Los Angeles, California, 90046, United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048, United States
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681, United States
HIV Institute / Davies Med Ctr
San Francisco, California, 94114, United States
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121, United States
Avalar Medical Group
Tarzana, California, 91356, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Benjamin Young
Denver, Colorado, 80220, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Hillsborough County Health Dept
Tampa, Florida, 33602, United States
Mercer University School of Medicine
Macon, Georgia, 31201, United States
Thomas Coffman MD
Boise, Idaho, 83712, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610, United States
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
Chicago, Illinois, 60611, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
University of Louisville / ID Division
Louisville, Kentucky, 40202, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Institute of Human Virology
Baltimore, Maryland, 21201, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Cooper Hospital Early Intervention Program
Camden, New Jersey, 08103, United States
Dr Ronald Nahass
Somerville, New Jersey, 08876, United States
Mt Vernon Hosp
Mount Vernon, New York, 10550, United States
Gramercy Park Physicians LLP
New York, New York, 10003, United States
St Luke Roosevelt Hosp
New York, New York, 10011, United States
St Vincents Hosp / Clinical Research Program
New York, New York, 10011, United States
Bellevue Hosp Ctr
New York, New York, 10016, United States
Mount Sinai Med Ctr
New York, New York, 100296574, United States
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153, United States
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157, United States
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, 73104, United States
Fanno Creek Clinic
Portland, Oregon, 97219, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213, United States
Univ of Texas Med Branch / Div of Infectious Dis
Galveston, Texas, 775550835, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 782847838, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 7, 2000
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2001-07