Search / Trial NCT00000653

A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT

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

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Trial Information

Current as of December 07, 2023

Completed

Keywords

Zalcitabine Drug Evaluation Acquired Immunodeficiency Syndrome Aids Related Complex

Description

As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent. Patients receive oral ddC for 48 to 177 weeks.

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Procrit.
  • Amphotericin B (1 mg/kg up to 5 days/week).
  • Prophylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia.
  • Acyclovir (up to 1000 mg/day PO; for > 1000 mg/day PO or for any IV dose, suggest interrupting ddC).
  • Ketoconazole (up to 10 mg/kg/day).
  • Nystatin.
  • Aspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours).
  • Isoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25
  • 50 mg/day to avoid possible INH-associated neuropathy.
  • Trimethoprim / sulfamethoxazole (T/S).
  • Immunoglobulin therapy.
  • Aerosolized pentamidine.
  • Drugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition.
  • Concurrent Treatment:
  • Allowed:
  • Immunoglobulin therapy.
  • Nutritional support (for children with wasting syndrome and/or malnutritional) including hyperalimentation (TPN) of dietary supplements.
  • AMENDED:
  • Patients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study.
  • ORIGINAL design:
  • Patients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol.
  • Patients must have the following:
  • Absence of acute opportunistic infection at time of entry.
  • However, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for > 4 weeks are eligible.
  • Parent or guardian available to give written informed consent.
  • Allowed at time of study entry:
  • Prophylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP).
  • Immunoglobulin therapy.
  • Prior Medication:
  • AMENDED:
  • AZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry
  • Allowed:
  • Zidovudine (AZT) within 4 weeks of entry.
  • Dideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI.
  • Other toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC.
  • Vitamin, folate, iron supplements.
  • Exclusion Criteria
  • Co-existing Condition:
  • AMENDED:
  • 04-25-91 Additional excluded symptoms and conditions:
  • Symptomatic cardiomyopathy.
  • Seizures which are not well controlled by ongoing anticonvulsant therapy.
  • Active malignancy requiring concomitant chemotherapy.
  • Symptomatic pancreatitis.
  • Grade I or greater peripheral neuropathy.
  • Receiving concomitant zidovudine (AZT).
  • Patients with the following conditions or symptoms are excluded:
  • Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
  • Known hypersensitivity to dideoxycytidine (ddC).
  • Concurrent Medication:
  • Excluded:
  • Other antiviral agents, biological modifiers, and investigational medications.
  • Drugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin.
  • Patients with the following are excluded:
  • Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
  • Known hypersensitivity to dideoxycytidine (ddC).
  • Active opportunistic infection requiring treatment with an excluded concomitant medication.
  • Prior Medication:
  • Excluded:
  • Antiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry.
  • Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
  • Any other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.

Attachments

readout_NCT00000653_2023-12-07.pdf

4.5 MB

NCT00000653_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

Oakland, California, United States

San Diego, California, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

Los Angeles, 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

Springfield, Massachusetts, United States

Worcester, Massachusetts, United States

New Brunswick, New Jersey, United States

Bronx, 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

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , 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

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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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