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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000733
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Ribavirin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 42
Study Completion Date: October 1991
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000733

Locations
United States, Louisiana
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Investigators
Study Chair: JJ Lertora
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000733     History of Changes
Other Study ID Numbers: ACTG 035, 11011
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ribavirin
T-Lymphocytes
Infusions, Intravenous
Immunologic Surveillance
Administration, Oral
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014