The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
- Conditions
- HIV Infections
- Registration Number
- NCT00005118
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Chicago Ctr for Clinical Research
🇺🇸Chicago, Illinois, United States
Bisher Akil
🇺🇸Los Angeles, California, United States
Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Anderson Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Texas Med Branch / Div of Infectious Dis
🇺🇸Galveston, Texas, United States
Univ of Texas Health Sciences Ctr
🇺🇸San Antonio, Texas, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Tower Infectious Diseases / Med Associates Inc
🇺🇸Los Angeles, California, United States
UCSD Med Ctr - Owen Clinic
🇺🇸San Diego, California, United States
Ocean View Internal Medicine
🇺🇸Long Beach, California, United States
San Francisco Veterans Adm Med Cntr
🇺🇸San Francisco, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Avalar Medical Group
🇺🇸Tarzana, California, United States
Benjamin Young
🇺🇸Denver, Colorado, United States
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
🇺🇸Chicago, Illinois, United States
University of Louisville / ID Division
🇺🇸Louisville, Kentucky, United States
Thomas Coffman MD
🇺🇸Boise, Idaho, United States
Hillsborough County Health Dept
🇺🇸Tampa, Florida, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Bronx Veterans Affairs Med Ctr
🇺🇸Bronx, New York, United States
SUNY at Stony Brook / Div of Infectious Disease
🇺🇸Stony Brook, New York, United States
Dr Ronald Nahass
🇺🇸Somerville, New Jersey, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
Mt Vernon Hosp
🇺🇸Mt. Vernon, New York, United States
St Luke Roosevelt Hosp
🇺🇸New York, New York, United States
St Vincents Hosp / Clinical Research Program
🇺🇸New York, New York, United States
Wake Forest Univ School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Cooper Hospital Early Intervention Program
🇺🇸Camden, New Jersey, United States
Fanno Creek Clinic
🇺🇸Portland, Oregon, United States
Bellevue Hosp Ctr
🇺🇸New York, New York, United States
HIV Institute / Davies Med Ctr
🇺🇸San Francisco, California, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Gramercy Park Physicians LLP
🇺🇸New York, New York, United States
Oklahoma Univ Health Science Ctr
🇺🇸Oklahoma City, Oklahoma, United States