A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).
Patients are selected from three patient groups:
* Patients with AIDS, who have not taken zidovudine (AZT) within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance.
* Patients with AIDS related ...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Short-course therapy (7 days) with oral acyclovir.
- • Short-course therapy (7 days) with ketoconazole.
- • Topical medications.
- • Aerosolized pentamidine for prophylactic purposes.
- Concurrent Treatment:
- Allowed:
- • Blood transfusions for hemoglobin toxicity.
- • Patients must have two positive HIV p24 antigen tests with titers = or \> 70 picograms at least 72 hours apart and within 1 month prior to entry, the last of which must be within 2 weeks of starting therapy.
- Prior Medication:
- Allowed:
- • Zidovudine (AZT), without cessation of therapy required due to intolerance.
- • AZT therapy must be discontinued at least 30 days prior to study entry.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following are excluded:
- • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \> 3 liquid stools per day within the past week.
- Concurrent Medication:
- Excluded:
- • Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
- • Antineoplastic therapy.
- • Other experimental medications.
- • Systemic chemoprophylaxis for Pneumocystis carinii pneumonia.
- • Chronic (\> 7 days) oral acyclovir therapy.
- Concurrent Treatment:
- Excluded:
- • Blood transfusions unless they are for = or \> grade 3 hemoglobin toxicity.
- Patients with the following are excluded:
- • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \> 3 liquid stools per day within the past week.
- Prior Medication:
- Excluded within 30 days of study entry:
- • Antiretroviral agents including zidovudine (AZT).
- • Biologic modifiers.
- • Systemic corticosteroids.
- Prior Treatment:
- Excluded within 2 months of study entry:
- • Blood transfusion except for those who have taken zidovudine (AZT) who may not have received a transfusion within the previous month.
- • Active drug or alcohol abuse.
Trial Officials
Crumpacker C
Study Chair
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
San Diego, California, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
San Francisco, California, United States
Boston, Massachusetts, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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