A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
ICN Pharmaceuticals
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000772
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic parameters with toxicity. To investigate antiviral activity of the combined regimen.

Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).


Condition Intervention Phase
HIV Infections
Drug: Ribavirin
Drug: Didanosine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals

Resource links provided by NLM:


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

Estimated Enrollment: 15
Study Completion Date: February 1995
Detailed Description:

Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).

Patients receive ddI alone for 4 weeks, followed by 8 weeks of combination ddI/ribavirin. Patients who complete the first 12 weeks without major toxicity may receive an additional 12 weeks of combination therapy on an optional basis. Patients are followed for 60 days after the last treatment visit.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Stable maintenance or prophylaxis therapy for opportunistic infection, if such therapy was administered for at least 30 days prior to study entry.
  • Isoniazid for chemoprophylaxis against Mycobacterium tuberculosis.
  • Fluconazole for mucosal candidiasis or cryptococcosis.
  • Acyclovir (up to 1.0 g/day).
  • Dapsone.
  • Ketoconazole.
  • Quinolones.
  • Tetracycline.
  • Vitamins and herbal therapies.
  • Antibiotics as clinically indicated.
  • Systemic corticosteroids for < 21 days for acute problems.
  • Regularly prescribed medications.

Patients must have:

  • HIV positivity by ELISA confirmed by Western blot.
  • CD4 count < 500 cells/mm3 within 30 days prior to study entry.
  • No active opportunistic infections requiring treatment (patients on stable maintenance and prophylaxis therapy for opportunistic infections for at least 30 days are permitted).

NOTE:

  • Enrollment of women is encouraged.

Prior Medication:

Allowed:

  • Prior stable maintenance or prophylaxis therapy for opportunistic infection, if administered for at least 30 days prior to study entry.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Concurrent rifampin or rifabutin.
  • Other anti-HIV drugs and investigational agents.
  • Biological response modifiers.
  • Ganciclovir or foscarnet.
  • Systemic cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

  • Concurrent radiation therapy other than limited localized therapy to the skin.

Patients with the following prior conditions are excluded:

  • History of peripheral neuropathy.
  • History of pancreatitis or active liver disease.

Prior Medication:

Excluded:

  • Prior ddI.
  • Ribavirin within 60 days prior to study entry.
  • AZT or ddC within 2 weeks prior to study entry.

Prior Treatment:

Excluded:

  • Transfusion within 2 weeks prior to study entry.

Active alcohol abuse.

  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: NCT00000772

Locations
United States, Massachusetts
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
United States, Minnesota
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Bristol-Myers Squibb
ICN Pharmaceuticals
Investigators
Study Chair: Japour AJ
Study Chair: Lertora JJ
Study Chair: Crumpacker C
  More Information

Additional Information:
Publications:
Japour AJ, et al. A Phase I study of the safety, tolerance, & pharmacokinetics of combination didanosine/ribavirin for HIV disease (ACTG 231). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:103

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000772     History of Changes
Other Study ID Numbers: ACTG 231, 11208
Study First Received: November 2, 1999
Last Updated: March 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ribavirin
Didanosine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

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

ClinicalTrials.gov processed this record on October 23, 2014