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NCT00005118

The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV-1 Drug Therapy, Combination HIV Protease Inhibitors Ritonavir Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Indinavir sulfate

Intervention Type DRUG

Ritonavir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Locations

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Pacific Oaks Research

Beverly Hills, California, United States

Site Status

Ocean View Internal Medicine

Long Beach, California, United States

Site Status

Bisher Akil

Los Angeles, California, United States

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Tower Infectious Diseases / Med Associates Inc

Los Angeles, California, United States

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UCSD Med Ctr - Owen Clinic

San Diego, California, United States

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HIV Institute / Davies Med Ctr

San Francisco, California, United States

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San Francisco Veterans Adm Med Cntr

San Francisco, California, United States

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Avalar Medical Group

Tarzana, California, United States

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Harbor - UCLA Med Ctr

Torrance, California, United States

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Benjamin Young

Denver, Colorado, United States

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University of Connecticut Health Center

Farmington, Connecticut, United States

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IDC Research Initiative

Altamonte Springs, Florida, United States

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Hillsborough County Health Dept

Tampa, Florida, United States

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Mercer University School of Medicine

Macon, Georgia, United States

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Thomas Coffman MD

Boise, Idaho, United States

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Chicago Ctr for Clinical Research

Chicago, Illinois, United States

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Northwestern Univ / Infect Dis Div / Pasavant Pav 828

Chicago, Illinois, United States

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The CORE Ctr

Chicago, Illinois, United States

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Univ of Kansas School of Medicine

Wichita, Kansas, United States

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University of Louisville / ID Division

Louisville, Kentucky, United States

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Tulane Univ School of Medicine

New Orleans, Louisiana, United States

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Institute of Human Virology

Baltimore, Maryland, United States

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New England Med Ctr

Boston, Massachusetts, United States

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Cooper Hospital Early Intervention Program

Camden, New Jersey, United States

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Dr Ronald Nahass

Somerville, New Jersey, United States

Site Status