Search / Trial NCT00000814

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Nevirapine

Description

The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance. In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Erythropoietin.
  • Concurrent Treatment:
  • Allowed:
  • Transfusion.
  • Patients must have:
  • Progressive HIV disease.
  • At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active malignancy requiring chemotherapy.
  • Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
  • Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.
  • Concurrent Medication:
  • Excluded (unless exemption made by study chair):
  • Oral anticoagulants (warfarin, dicumarol).
  • Oral contraceptives.
  • Digitalis glycosides.
  • Phenytoin.
  • Theophylline.
  • Patients with the following prior conditions are excluded:
  • History of clinical pancreatitis.
  • History of grade 2 or worse peripheral neuropathy.
  • Prior Treatment:
  • Excluded:
  • Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.

Attachments

readout_NCT00000814_2024-05-23.pdf

4.5 MB

NCT00000814_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

Seattle, Washington, United States

Bronx, New York, United States

Birmingham, Alabama, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Oakland, California, United States

San Francisco, California, United States

Denver, Colorado, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, 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

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

New Brunswick, New Jersey, United States

Newark, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, 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

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Valhalla, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Providence, Rhode Island, United States

Charleston, South Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Hershey, Pennsylvania, United States

Farmington, Connecticut, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Jacksonville, Florida, United States

Durham, North Carolina, United States

Dayton, Ohio, United States

New York, New York, United States

Norfolk, Virginia, United States

Bronx, New York, United States

Hershey, Pennsylvania, 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
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

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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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