Clinical trial NCT00005118: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Research
state: California
city: Long Beach
country: United States
facility: Ocean View Internal Medicine
state: California
city: Los Angeles
country: United States
facility: Bisher Akil
state: California
city: Los Angeles
country: United States
facility: Tower Infectious Diseases / Med Associates Inc
state: California
city: San Diego
country: United States
facility: UCSD Med Ctr - Owen Clinic
state: California
city: San Francisco
country: United States
facility: HIV Institute / Davies Med Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Adm Med Cntr
state: California
city: Tarzana
country: United States
facility: Avalar Medical Group
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Denver
country: United States
facility: Benjamin Young
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Dept
state: Florida
city: Macon
country: United States
facility: Mercer University School of Medicine
state: Georgia
city: Boise
country: United States
facility: Thomas Coffman MD
state: Idaho
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Northwestern Univ / Infect Dis Div / Pasavant Pav 828
state: Illinois
city: Chicago
country: United States
facility: The CORE Ctr
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Louisville
country: United States
facility: University of Louisville / ID Division
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine
state: Louisiana
city: Baltimore
country: United States
facility: Institute of Human Virology
state: Maryland
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Camden
country: United States
facility: Cooper Hospital Early Intervention Program
state: New Jersey
city: Somerville
country: United States
facility: Dr Ronald Nahass
state: New Jersey
city: Bronx
country: United States
facility: Bronx Veterans Affairs Med Ctr
state: New York
city: Mt. Vernon
country: United States
facility: Mt Vernon Hosp
state: New York
city: New York
country: United States
facility: Gramercy Park Physicians LLP
state: New York
city: New York
country: United States
facility: St Luke Roosevelt Hosp
state: New York
city: New York
country: United States
facility: St Vincents Hosp / Clinical Research Program
state: New York
city: New York
country: United States
facility: Bellevue Hosp Ctr
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Stony Brook
country: United States
facility: SUNY at Stony Brook / Div of Infectious Disease
state: New York
city: Winston Salem
country: United States
facility: Wake Forest Univ School of Medicine
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Univ Health Science Ctr
state: Oklahoma
city: Portland
country: United States
facility: Fanno Creek Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Galveston
country: United States
facility: Univ of Texas Med Branch / Div of Infectious Dis
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: San Antonio
country: United States
facility: Univ of Texas Health Sciences Ctr
state: Texas
Study officials:
References: