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Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients

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, Infusions, Intravenous, Immunologic Surveillance, Administration, Oral, Acquired Immunodeficiency Syndrome

Eligibility Criteria

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

Inclusion Criteria Patients must be asymptomatic according to the following criteria: Normal neurologic exam. No unintentional weight loss of greater than 10 lbs. or more than 10 percent of usual body weight within 2 years prior to entering the study. No unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30 days in the 2 years prior to expected entry into the study. No unexplained diarrhea defined by equal to or more than 3 liquid stools per day persisting more than 7 days within 2 years prior to expected entry into the study. No active hepatitis of any form. In addition, patients must not have previously had AIDS or an AIDS related illness. Exclusion Criteria Co-existing Condition: Excluded: Temperature of greater than 37.8 degrees C. Development of an AIDS-defining opportunistic infection. Unexplained diarrhea defined by equal to or more than 3 liquid stools per day. Active hepatitis of any form. Patients who have had oral candida infection documented by morphology, or by response to antifungal therapy, or oral hairy leukoplakia, or herpes zoster infection within 2 years of anticipated study entry at any time will be excluded. Patients with a prior history of a malignancy other than cutaneous basal cell carcinomas or cervical carcinoma in situ and patients with a significant chronic underlying medical illness that would impair continuous participation in the study will be excluded. Prior Medication: Excluded within 90 days of study entry: Immunomodulators. Active alcohol or drug abuse sufficient in the investigator's opinion to prevent adequate compliance with the study therapy.

Sites / Locations

  • Charity Hosp / Tulane Univ Med School
  • Tulane Univ School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000733
Brief Title
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
Official Title
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
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
October 1991 (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 how fast ribavirin reaches the bloodstream, what concentration of ribavirin is reached in blood and how long it remains in the blood (pharmacokinetics) when given by different routes of administration. To find the maximum tolerated dose (MTD) of ribavirin. The effects of ribavirin on the immune system, and on the virus will be measured by T4 cell count and p24 antigen levels. Early studies with ribavirin in patients with AIDS and AIDS related complex (ARC) have shown that ribavirin appears to inhibit the spread of the virus. Determination of how much and how often to give the drug will require further knowledge of the pharmacokinetics and toxicity of the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms.
Detailed Description
Early studies with ribavirin in patients with AIDS and AIDS related complex (ARC) have shown that ribavirin appears to inhibit the spread of the virus. Determination of how much and how often to give the drug will require further knowledge of the pharmacokinetics and toxicity of the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms. Ribavirin is given to HIV-infected patients intravenously as a timed 30-min infusion at 1 of 5 single doses; 2 weeks later, the same doses are given orally in a single dose. Following at least 2 additional weeks, 6 patients are then given ribavirin at the lowest dose twice a day for 16 weeks. They are evaluated for tolerance and the next group is given a higher dose. Each successive group begins at 3-week intervals to receive doses that increase each day until the MTD is reached. Blood samples taken periodically during the treatment period and for 8 weeks after treatment is stopped are used to measure blood levels of ribavirin and to determine the effects of ribavirin on the HIV and immune system of the patients.

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, Infusions, Intravenous, Immunologic Surveillance, Administration, Oral, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
42 (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 Patients must be asymptomatic according to the following criteria: Normal neurologic exam. No unintentional weight loss of greater than 10 lbs. or more than 10 percent of usual body weight within 2 years prior to entering the study. No unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30 days in the 2 years prior to expected entry into the study. No unexplained diarrhea defined by equal to or more than 3 liquid stools per day persisting more than 7 days within 2 years prior to expected entry into the study. No active hepatitis of any form. In addition, patients must not have previously had AIDS or an AIDS related illness. Exclusion Criteria Co-existing Condition: Excluded: Temperature of greater than 37.8 degrees C. Development of an AIDS-defining opportunistic infection. Unexplained diarrhea defined by equal to or more than 3 liquid stools per day. Active hepatitis of any form. Patients who have had oral candida infection documented by morphology, or by response to antifungal therapy, or oral hairy leukoplakia, or herpes zoster infection within 2 years of anticipated study entry at any time will be excluded. Patients with a prior history of a malignancy other than cutaneous basal cell carcinomas or cervical carcinoma in situ and patients with a significant chronic underlying medical illness that would impair continuous participation in the study will be excluded. Prior Medication: Excluded within 90 days of study entry: Immunomodulators. Active alcohol or drug abuse sufficient in the investigator's opinion to prevent adequate compliance with the study therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JJ Lertora
Official's Role
Study Chair
Facility Information:
Facility Name
Charity Hosp / Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1680594
Citation
Lertora JJ, Rege AB, Lacour JT, Ferencz N, George WJ, VanDyke RB, Agrawal KC, Hyslop NE Jr. Pharmacokinetics and long-term tolerance to ribavirin in asymptomatic patients infected with human immunodeficiency virus. Clin Pharmacol Ther. 1991 Oct;50(4):442-9. doi: 10.1038/clpt.1991.162.
Results Reference
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Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients

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