The Safety and Effectiveness of Ribavirin in the Early Stages of HIV-Infection

June 23, 2005 updated by: ICN Pharmaceuticals

Long-Term Efficacy and Tolerance of Oral Ribavirin Compared to Placebo as a Preventative in Early Stages of Human Immunodeficiency Virus Infection - United States

The objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV disease as defined by CDC classification, and whether the dosage regimen is safe and tolerable in these subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Acyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • CDC classification group IV A (ARC).
  • CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years). Positive plasma p24 antigen.
  • Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
  • Splenectomy.

Concurrent Medication:

Excluded:

  • Isoprinosine.

Patients with the following are excluded:

  • Failure to give informed consent.
  • CDC classification group IV A (ARC).
  • CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years).

Positive plasma p24 antigen.

  • Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
  • Splenectomy.

Prior Medication:

Excluded within 4 weeks of start of screening tests:

  • Zidovudine.
  • Other drug with scientifically accepted anti-HIV properties.
  • Scientifically accepted immunostimulant treatment.
  • Immunosuppressant.
  • Myelosuppressant or other known toxic drugs.

HIV infection group II (CDC), asymptomatic HIV infection.

  • HIV antibody positive by Western blot with antibodies to p24 band and GP160 band and/or GP41. Two positive tests during screening will be required. CDC HIV infection group II, asymptomatic HIV infection, as defined in Appendix A, or CDC HIV infection group III, persistent generalized lymphadenopathy (PGL, formerly LAS).
  • OKT4+ lymphocyte count greater than 300 cells/mm3 and less than 600 cells/mm3. The counts will be determined on three separate evaluations separated by at least 7 days between evaluations. These three counts will be averaged and for inclusion in the study the mean of the OKT4+ lymphocyte count must be greater than 200 cells/mm3 and less than 600 cells/mm3. Conclusion of screening tests:
  • Within 42 days of starting them. Patients must be entered into the study within 14 days of screening completion. Ability to participate as outpatient:
  • Ambulatory, competent to sign informed consent, and able to cooperate with the treatment plan and evaluation schedule. Informed consent:
  • Must be signed before randomization to treatment. Physical activity evaluation with Karnofsky score greater than or equal to 90.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICN Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Ribavirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe