Status:
COMPLETED
A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dos...
Detailed Description
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 a...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 1990
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00001015
End Date
June 1 1990
Last Update
November 1 2021
Active Locations (5)
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1
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
2
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
3
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
4
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016