Search / Trial NCT00000831

Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

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

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Didanosine Drug Therapy, Combination Aids Related Complex Antiviral Agents Zidovudine Stavudine Lamivudine Drug Combinations

Description

Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone. Patients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDM...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Recommended:
  • PCP prophylaxis in patients with CD4 count <= 200 cells/mm3.
  • Allowed:
  • Chemophylaxis against Mycobacterium tuberculosis.
  • Acyclovir.
  • Vaccination with pneumococcal vaccine polyvalent.
  • Haemophilus B Conjugate vaccine.
  • Chemoprophylaxis for MAC and Toxoplasma gondii.
  • Antibiotics.
  • Recombinant erythropoietin ( EPO ) and G-CSF.
  • Systemic corticosteroids for < 21 days.
  • Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives.
  • Vitamins and herbal therapies.
  • Concurrent Treatment:
  • Allowed:
  • Limited local radiation therapy to skin.
  • Blood transfusions if 3 units or less per 21-day period.
  • Acupuncture.
  • Visualization techniques.
  • Patients must have:
  • Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval.
  • Not reached an ACTG 175 endpoint prior to May 1, 1995.
  • Consent of parent or guardian if less than 18 years old.
  • PER AMENDMENT 8/27/96:
  • Patients must be on study/on treatment at the time the protocol study treatment is extended.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Grade 2 or worse peripheral neuropathy.
  • Malignancy requiring systemic therapy.
  • Concurrent Medication:
  • Excluded:
  • Anti-HIV drugs other than study drugs.
  • Biologic response modifiers.
  • Systemic cytotoxic chemotherapy.
  • Any drug known to affect glucuronidation and/or clearance of AZT.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy other than limited local therapy to skin.
  • Patients with the following prior condition are excluded:
  • History of acute or chronic pancreatitis.
  • Prior Medication:
  • Excluded:
  • Prior 3TC.
  • Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry.
  • Current ethanol abuse.

Attachments

readout_NCT00000831_2024-06-13.pdf

4.5 MB

NCT00000831_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

Birmingham, Alabama, United States

Los Angeles, California, United States

Los Angeles, California, United States

Palo Alto, California, United States

San Diego, California, United States

San Francisco, California, United States

San Jose, California, United States

San Mateo, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

San Juan, , Puerto Rico

Mbeya, , Tanzania

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
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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

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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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