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Clinical Trials

MainTitle

A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000699

First received: November 2, 1999
Last updated: August 25, 2008
Last Verified: April 2003
History of Changes
Purpose

Purpose

To determine the safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine (INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV). Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when RBV is given with INPX. The patients may or may not have generalized lymphadenopathy syndrome (LAS). RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV. The immune system fights infections in the human body, and the HIV attacks T cells that are an important part of the immune system. Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients, but there is no reliable information on the safety and effectiveness of this drug combination in such patients.

Condition Intervention Phase
HIV Infections

Drug : Inosine pranobex
Drug : Ribavirin
Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients

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

Enrollment: 20

Detailed Description:

RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV. The immune system fights infections in the human body, and the HIV attacks T cells that are an important part of the immune system. Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients, but there is no reliable information on the safety and effectiveness of this drug combination in such patients.
All patients take INPX capsules 4 times a day and RBV capsules 2 or 3 times a day. The first group of patients take the dose of RBV shown to be effective in an earlier trial and subsequent groups take higher doses until toxic effects occur. The planned treatment period is 3 months, but further treatment may be allowed for patients showing improvement. Blood samples are taken from an arm vein and used to evaluate possible changes in the patient's immune system, any toxic effects that might be detected in the blood and possible changes in the presence of HIV in the blood.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 75 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria

  • It must be possible to culture HIV from peripheral blood lymphocytes on 2 consecutive screenings within 2 months of starting treatment.

  • Concurrent Medication:
    Allowed:
  • Systemic medications not listed in the Exclusion Concurrent Medications field considered necessary for the patient's medical management and which would not interfere with the study may be used, but such use must be documented.

  • Exclusion Criteria
    Concurrent Medication:
    Excluded:
  • Systemic steroids.
  • Cytotoxic immunosuppressive medications.
  • Any systemic experimental anti-HIV drug such as dideoxycytidine (ddC), foscarnet, ribavirin, isoprinosine, or zidovudine (AZT).
  • Any other medication felt to be immunomodulatory or felt to exhibit significant hepatotoxicity or hematologic or renal toxicity by study investigators.

  • Prior Medication:
    Excluded within 6 weeks of study entry:
  • Systemic steroids.
  • Cytotoxic immunosuppressive medications.
  • Any systemic experimental anti-HIV drug such as dideoxycytidine (ddC), foscarnet, ribavirin, isoprinosine, or zidovudine (AZT).
  • Any other medication felt to be immunomodulatory or felt to exhibit significant hepatotoxicity or hematologic or renal toxicity by study investigators.

  • Current active infections, known cardiac disease, or prior history of one of the following:
  • Gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction.
  • Neoplasms:
  • Other than locally treated basal or squamous carcinoma.
  • Cardiovascular:
  • Myocardial infarction, cardiac arrhythmia, cardiomyopathy, or congestive heart
failure.
Past or current history of CDC-defined AIDS including HIV encephalopathy and HIV wasting syndrome. Constitutional symptoms (CDC Group IV-A), neurologic symptoms (CDC Group IV-B), or any prior or current non-AIDS defining secondary infectious disease (CDC Group IV-C2). Grade 1 impairment on 2 or more items in the ACTG Micro Neuro-AIDS Assessment.
Active drug or alcohol abuse.

contacts and locations

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: NCT00000699

Locations

United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Schulof RS
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000699   History of Changes  
Other Study ID Numbers: NS 403  
Study First Received: November 2, 1999  
Last Updated: August 25, 2008  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Ribavirin
Inosine Pranobex
Dose-Response Relationship, Drug
Drug Evaluation
Drug Therapy, Combination
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Ribavirin
Inosine Pranobex

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.