Completed

A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems

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What is being tested

Ribavirin

Drug
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

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 dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood. 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). 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 diseases who have not taken AZT within 30 days of entry into the study, and who have not been discontinued from AZT because of intolerance. * Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy. This is an outpatient study; patients are seen weekly for the first 4 weeks, every other week through week 12, and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study. Patients from each of the three diagnostic groups are enrolled at each dose level. For the first 3 days after entry into the study, all patients receive the lowest dose of RBV every 6 hours. Subsequent dosages increase until the maximum tolerated dose (MTD) is reached. The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage. Patients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance.

Official TitleA Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
96 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
Univ of California / San Diego Treatment CtrSan Diego, United StatesSee the location
Suspended
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United States
Suspended
Harvard (Massachusetts Gen Hosp)Boston, United States
Suspended
Bellevue Hosp / New York Univ Med CtrNew York, United States

Completed5 Study Centers