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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ribavirin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Ribavirin, T-Lymphocytes, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of California / San Diego Treatment Ctr
  • San Francisco AIDS Clinic / San Francisco Gen Hosp
  • Harvard (Massachusetts Gen Hosp)
  • Bellevue Hosp / New York Univ Med Ctr
  • Univ of North Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001015
Brief Title
A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems
Official Title
A Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1990 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 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).
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Ribavirin, T-Lymphocytes, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
96 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ribavirin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crumpacker C
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Harvard (Massachusetts Gen Hosp)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Crumpacker C, Pearlstein G, van der Horst C, Valentine F, Spector S, Mills J. A phase one increasing dose trial of oral ribavirin (RBV) in patients with AIDS and ARC. Int Conf AIDS. 1990 Jun 20-23;6(3):203 (abstract no SB468)
Results Reference
background
Citation
Crumpacker C, Cotton D, Pearlstein G, Valentine F, Mills J, Spector S. Ribavirin dose escalating phase 1 trial in patients with AIDS and ARC. Int Conf AIDS. 1989 Jun 4-9;5:336 (abstract no TBP296)
Results Reference
background

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

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