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
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Patients applied
Trial Officials
Merigan TC
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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