Back to resultsThe Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Nelfinavir
Eligibility Criteria
Inclusion Criteria 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.
Sites / Locations
- Pacific Oaks Research
- Ocean View Internal Medicine
- Bisher Akil
- Tower Infectious Diseases / Med Associates Inc
- UCSD Med Ctr - Owen Clinic
- HIV Institute / Davies Med Ctr
- San Francisco Veterans Adm Med Cntr
- Avalar Medical Group
- Harbor - UCLA Med Ctr
- Benjamin Young
- University of Connecticut Health Center
- IDC Research Initiative
- Hillsborough County Health Dept
- Mercer University School of Medicine
- Thomas Coffman MD
- Chicago Ctr for Clinical Research
- Northwestern Univ / Infect Dis Div / Pasavant Pav 828
- The CORE Ctr
- Univ of Kansas School of Medicine
- University of Louisville / ID Division
- Tulane Univ School of Medicine
- Institute of Human Virology
- New England Med Ctr
- Cooper Hospital Early Intervention Program
- Dr Ronald Nahass
- Bronx Veterans Affairs Med Ctr
- Mt Vernon Hosp
- Gramercy Park Physicians LLP
- St Luke Roosevelt Hosp
- St Vincents Hosp / Clinical Research Program
- Bellevue Hosp Ctr
- Mount Sinai Med Ctr
- SUNY at Stony Brook / Div of Infectious Disease
- Wake Forest Univ School of Medicine
- Oklahoma Univ Health Science Ctr
- Fanno Creek Clinic
- Anderson Clinical Research
- Univ of Texas Med Branch / Div of Infectious Dis
- Thomas Street Clinic
- Univ of Texas Health Sciences Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00005118
Brief Title
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2001
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
Detailed Description
Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Nelfinavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Ritonavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Facility Information:
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Ocean View Internal Medicine
City
Long Beach
State/Province
California
ZIP/Postal Code
90803
Country
United States
Facility Name
Bisher Akil
City
Los Angeles
State/Province
California
ZIP/Postal Code
90046
Country
United States
Facility Name
Tower Infectious Diseases / Med Associates Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCSD Med Ctr - Owen Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
921038681
Country
United States
Facility Name
HIV Institute / Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
San Francisco Veterans Adm Med Cntr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Avalar Medical Group
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Benjamin Young
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Hillsborough County Health Dept
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Mercer University School of Medicine
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Thomas Coffman MD
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Louisville / ID Division
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Cooper Hospital Early Intervention Program
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Dr Ronald Nahass
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Bronx Veterans Affairs Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Mt Vernon Hosp
City
Mt. Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
Gramercy Park Physicians LLP
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
St Luke Roosevelt Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St Vincents Hosp / Clinical Research Program
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Bellevue Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
100296574
Country
United States
Facility Name
SUNY at Stony Brook / Div of Infectious Disease
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Wake Forest Univ School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oklahoma Univ Health Science Ctr
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Fanno Creek Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Univ of Texas Med Branch / Div of Infectious Dis
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Univ of Texas Health Sciences Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
782847838
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
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