Completed
A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
15
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
Status Unknown
2
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here