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

Sponsor:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00005118

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Ritonavir	Phase II

Study Type:	Interventional
Study Design:	Treatment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Indinavir Ritonavir Indinavir Sulfate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

100

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005118

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Locations

United States, California
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
UCSD Med Ctr - Owen Clinic
San Diego, California, United States, 921038681
San Francisco Veterans Adm Med Cntr
San Francisco, California, United States, 94121
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, United States, 90048
Pacific Oaks Research
Beverly Hills, California, United States, 90211
HIV Institute / Davies Med Ctr
San Francisco, California, United States, 94114
Ocean View Internal Medicine
Long Beach, California, United States, 90803
Avalar Medical Group
Tarzana, California, United States, 91356
Bisher Akil
Los Angeles, California, United States, 90046
United States, Colorado
Benjamin Young
Denver, Colorado, United States, 80220
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
United States, Georgia
Mercer University School of Medicine
Macon, Georgia, United States, 31201
United States, Idaho
Thomas Coffman MD
Boise, Idaho, United States, 83712
United States, Illinois
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
Chicago, Illinois, United States, 60611
The CORE Ctr
Chicago, Illinois, United States, 60612
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Kentucky
University of Louisville / ID Division
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maryland
Institute of Human Virology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, New Jersey
Dr Ronald Nahass
Somerville, New Jersey, United States, 08876
Cooper Hospital Early Intervention Program
Camden, New Jersey, United States, 08103
United States, New York
St Luke Roosevelt Hosp
New York, New York, United States, 10011
Bellevue Hosp Ctr
New York, New York, United States, 10016
St Vincents Hosp / Clinical Research Program
New York, New York, United States, 10011
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, United States, 117948153
Bronx Veterans Affairs Med Ctr
Bronx, New York, United States, 10468
Mount Sinai Med Ctr
New York, New York, United States, 100296574
Mt Vernon Hosp
Mt. Vernon, New York, United States, 10550
Gramercy Park Physicians LLP
New York, New York, United States, 10003
United States, North Carolina
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Oklahoma
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Fanno Creek Clinic
Portland, Oregon, United States, 97219
United States, Pennsylvania
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Univ of Texas Med Branch / Div of Infectious Dis
Galveston, Texas, United States, 775550835
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States, 782847838
Thomas Street Clinic
Houston, Texas, United States, 77009

Sponsors and Collaborators

Merck

More Information

No publications provided

Study ID Numbers:	246V, CRX481, 107-00
Study First Received:	April 7, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005118 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Indinavir

Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
HIV Protease Inhibitors

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009