Search / Trial NCT00000924

A Study to Compare Two Different Anti-HIV Drug Regimens

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Drug Therapy, Combination Hiv Protease Inhibitors Reverse Transcriptase Inhibitors Anti Hiv Agents

Description

The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults. However, as of yet, few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected, antiretroviral-experienced children. Evidence suggests that viral suppression may be more difficult to achieve in children. Therefore, it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children. Patients are stratified by prior antiretroviral treatment (zidovudine [ZDV]/la...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients may be eligible for this study if they:
  • Are between 4 months and 21 years of age (consent of parent or guardian required if under 18).
  • Are HIV-positive.
  • Have a viral level of at least 4,000 copies/ml.
  • Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months.
  • Have received the same continuous antiretroviral therapy for the past 16 weeks.
  • Exclusion Criteria
  • Patients will not be eligible for this study if they:
  • Have an active opportunistic and/or serious bacterial infection.
  • Have been diagnosed with a malignancy.
  • Have received prior treatment with certain antiretroviral medications.
  • Are pregnant or breast-feeding.

Attachments

readout_NCT00000924_2024-03-02.pdf

4.5 MB

NCT00000924_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Springfield, Massachusetts, United States

Bronx, New York, United States

Long Beach, California, United States

Los Angeles, California, United States

Oakland, California, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Great Neck, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Newark, New Jersey, United States

Bronx, New York, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Birmingham, Alabama, United States

Mobile, Alabama, United States

Fort Lauderdale, Florida, United States

Gainesville, Florida, United States

New Orleans, Louisiana, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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