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



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

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Merck ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 100

Location and Contact Information:

Dr Ronald Nahass
Somerville,  New Jersey,  08876
United States
 

Mount Sinai Med Ctr
New York City,  New York,  100296574
United States
 

Thomas Street Clinic
Houston,  Texas,  77009
United States
 

Gramercy Park Physicians LLP
New York City,  New York,  10003
United States
 

Bellevue Hosp Ctr
New York City,  New York,  10016
United States
 

SUNY at Stony Brook / Div of Infectious Disease
Stony Brook,  New York,  117948153
United States
 

Univ of Texas Health Sciences Ctr
San Antonio,  Texas,  782847838
United States
 

Tower Infectious Diseases / Med Associates Inc
Los Angeles,  California,  90048
United States
 

Northwestern Univ / Infect Dis Div / Pasavant Pav 828
Chicago,  Illinois,  60611
United States
 

Univ of Kansas School of Medicine
Wichita,  Kansas,  67214
United States
 

Wake Forest Univ School of Medicine
Winston Salem,  North Carolina,  27157
United States
 

The CORE Ctr
Chicago,  Illinois,  60612
United States
 

Univ of Texas Med Branch / Div of Infectious Dis
Galveston,  Texas,  775550835
United States
 

IDC Research Initiative
Altamonte Springs,  Florida,  32701
United States
 

HIV Institute / Davies Med Ctr
San Francisco,  California,  94114
United States
 

Fanno Creek Clinic
Portland,  Oregon,  97219
United States
 

New England Med Ctr
Boston,  Massachusetts,  02111
United States
 

UCSD Med Ctr - Owen Clinic
San Diego,  California,  921038681
United States
 

Avalar Medical Group
Tarzana,  California,  91356
United States
 

Cooper Hospital Early Intervention Program
Camden,  New Jersey,  08103
United States
 

Bisher Akil
Los Angeles,  California,  90046
United States
 

Mercer University School of Medicine
Macon,  Georgia,  31201
United States
 

Anderson Clinical Research
Pittsburgh,  Pennsylvania,  15213
United States
 

Pacific Oaks Research
Beverly Hills,  California,  90211
United States
 

St Luke Roosevelt Hosp
New York City,  New York,  10011
United States
 

Oklahoma Univ Health Science Ctr
Oklahoma City,  Oklahoma,  73104
United States
 

Mt Vernon Hosp
Mt. Vernon,  New York,  10550
United States
 

Ocean View Internal Medicine
Long Beach,  California,  90803
United States
 

St Vincents Hosp / Clinical Research Program
New York City,  New York,  10011
United States
 

University of Louisville / ID Division
Louisville,  Kentucky,  40202
United States
 

Tulane Univ School of Medicine
New Orleans,  Louisiana,  70112
United States
 

Benjamin Young
Denver,  Colorado,  80220
United States
 

Chicago Ctr for Clinical Research
Chicago,  Illinois,  60610
United States
 

Hillsborough County Health Dept
Tampa,  Florida,  33602
United States
 

Institute of Human Virology
Baltimore,  Maryland,  21201
United States
 

University of Connecticut Health Center
Farmington,  Connecticut,  06030
United States
 

Harbor - UCLA Med Ctr
Torrance,  California,  90502
United States
 

Thomas Coffman MD
Boise,  Idaho,  83712
United States
 

Bronx Veterans Affairs Med Ctr
Bronx,  New York,  10468
United States
 

San Francisco Veterans Adm Med Cntr
San Francisco,  California,  94121
United States
 


Additional Information:
Study ID Numbers:
  246V;  CRX481,107-00
Study Start Date: 
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005118

Other Hiv Infections Studies:
1. A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children with Immunodeficiency Syndromes

2. A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

3. A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

4. The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease

5. The Effect of Teaching HIV-Infected Patients about HIV and Treatment

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

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