Search / Trial NCT00000704

A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.

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

Hiv Antigens Immunologic Surveillance Zalcitabine Dose Response Relationship, Drug Acquired Immunodeficiency Syndrome Aids Related Complex Cd4 Positive T Lymphocytes

Description

Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in certain patients with AIDS. A range of doses of ddC is given to patients with AIDS and ARC. Eight patients with AIDS and eight patients with ARC are given ddC at the lowest level for 12 weeks. Patients who respond with a rise in their number of T4 cells or with a fall in HIV antigen in their serum (the fluid portion of t...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aspirin, acetaminophen, and nonsteroidal anti-inflammatory agents.
  • Acute therapy (7 days) with oral acyclovir.
  • Acute therapy with ketoconazole.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Negative antigen test within 2 weeks of starting therapy.
  • Significant malabsorption (> 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or vitamin A < 75 IU/ml).
  • Significant cardiac, liver, or neurologic disease.
  • For group A:
  • Opportunistic infection or malignancy fulfilling definition of AIDS, or with concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • For group B:
  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or with concurrent neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix.
  • Concurrent Medication:
  • Excluded:
  • Acyclovir therapy.
  • Chemoprophylaxis for Pneumocystis carinii pneumonia.
  • Other antiretroviral agents, biologic modifiers, or systemic corticosteroids.
  • Other experimental medications, sedatives, and barbiturates.
  • Group B:
  • Therapy and/or prophylaxis for AIDS-defining opportunistic infection, antineoplastic therapy.
  • Concurrent Treatment:
  • Excluded:
  • - Transfusion dependency (requiring 2 units of blood more than once per month). Patients with history of idiopathic thrombocytopenia purpura are excluded.
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Biologic modifiers or corticosteroids.
  • Excluded within 90 days of study entry:
  • Antiretroviral agents.
  • Prior Treatment:
  • Excluded within 2 weeks of study entry:
  • Transfusion.
  • Inclusion criteria are:
  • Consistently positive HIV antigen as defined by Abbott HIV antigen test. This demonstration will be seen on two occasions, each separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy.
  • HIV antigen titer must be = or > 100 pg.
  • Positive antibody to HIV confirmed by any federally licensed enzyme-linked immunosorbent assay (ELISA) test kit.
  • The following conditions are allowed:
  • - Basal cell carcinoma of the skin or in situ carcinoma of the cervix. Active substance abuse.

Attachments

readout_NCT00000704_2024-06-13.pdf

4.5 MB

NCT00000704_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

Miami, Florida, 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

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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?

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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