Search / Trial NCT00001066

A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children

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 Lamivudine

Description

Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile. Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continu...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • IVIG.
  • Prophylaxis for opportunistic infection.
  • EPO.
  • G-CSF or GM-CSF.
  • Patients must have:
  • Symptomatic HIV infection.
  • Less than 56 days of prior antiretroviral therapy.
  • Consent of parent or guardian.
  • NOTE:
  • Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.
  • Prior Medication:
  • Allowed:
  • Up to 56 days of prior antiretroviral therapy.
  • Prior immunomodulator therapy.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Malignancy.
  • Hypersensitivity to a nucleoside analog.
  • Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.
  • PER AMENDMENT 4/29/96:
  • Active opportunistic infection and/or serious bacterial infection at the time of entry.
  • Concurrent Medication:
  • Excluded:
  • Any other anti-HIV therapy.
  • Megestrol acetate ( Megace ).
  • Probenecid.
  • IV pentamidine.
  • Human growth hormone ( hGH ).
  • Systemic corticosteroids for more than 2 weeks.
  • Prior Medication:
  • Excluded:
  • Investigational drug therapy within 14 days prior to study entry.

Attachments

readout_NCT00001066_2024-05-23.pdf

4.5 MB

NCT00001066_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

New York, New York, 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

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

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

Boston, Massachusetts, United States

Detroit, Michigan, United States

New Brunswick, New Jersey, United States

Newark, 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

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

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Providence, Rhode Island, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Newark, New Jersey, United States

Los Angeles, California, United States

Stanford, California, United States

Tampa, Florida, United States

Augusta, Georgia, United States

Farmington, Connecticut, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Jacksonville, Florida, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Jackson, Mississippi, United States

Norfolk, Virginia, United States

Orlando, Florida, United States

Columbia, South Carolina, United States

Little Rock, Arkansas, United States

Sacramento, California, United States

Fort Lauderdale, Florida, United States

Gainesville, Florida, United States

St Petersburg, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Savannah, Georgia, United States

Chicago, Illinois, United States

Minneapolis, Minnesota, United States

St Louis, Missouri, United States

Buffalo, New York, United States

Dayton, Ohio, United States

Fort Worth, Texas, United States

San Antonio, Texas, United States

Richmond, Virginia, United States

Mayaguez, , Puerto Rico

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

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?

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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