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

NCT ID: NCT00000772

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1995-02-28

Brief Summary

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).

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.

Conditions

HIV Infections

Keywords

Ribavirin; Didanosine; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Ribavirin

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

ICN Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Japour AJ

Role: STUDY_CHAIR

Lertora JJ

Role: STUDY_CHAIR

Crumpacker C

Role: STUDY_CHAIR

Locations

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, United States

University of Minnesota, ACTU

Minneapolis, Minnesota, United States

Countries

United States

References

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

Reference Type: BACKGROUND

Other Identifiers

11208

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 231

Identifier Type: -

Identifier Source: org_study_id