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A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000699
  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 I

MedlinePlus related topics: AIDS
Drug Information available for: Ribavirin Inosine Inosine pranobex
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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):

Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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
Investigators
Study Chair: Schulof RS
  More Information

Click here for more information about Ribavirin  This link exits the ClinicalTrials.gov site

Publications:
Schulof R, Simon G, Parenti D, Sztein M, Meyer W, Paxton H. Phase I/II trial of ribavirin + isoprinosine in asymptomatic HIV viremic gay men. Int Conf AIDS. 1989 Jun 4-9;5:212 (abstract no ThBO2)
Schulof RS, Parenti DM, Simon GL, Paxton H, Meyer WA 3rd, Schlesselman SB, Courtless J, LeLacheur S, Sztein MB. Clinical, virologic, and immunologic effects of combination therapy with ribavirin and isoprinosine in HIV-infected homosexual men. J Acquir Immune Defic Syndr. 1990;3(5):485-92.

Study ID Numbers: NS 403
Study First Received: November 2, 1999
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00000699  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Ribavirin
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Inosine Pranobex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Infection
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 15, 2009