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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00005118
Other study ID # 246V
Secondary ID CRX481107-00
Status Active, not recruiting
Phase Phase 2
First received April 7, 2000
Last updated June 23, 2005

Study information

Verified date July 2001
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Indinavir sulfate

Ritonavir


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

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