HIV InfectionsPhase 1NCT00000772
A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
A Phase 1 study testing Ribavirin and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ribavirin and Didanosine
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Feb 1995
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 23Show fewer
- 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.
Who cannot join
- Concurrent Medication:
- Excluded:
- Concurrent rifampin or rifabutin.
- Other anti-HIV drugs and investigational agents.
- Biological response modifiers.
- Ganciclovir or foscarnet.
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455
About this study
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).
Read the 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
- Being tested
- Ribavirin, Didanosine
- Keywords
- Ribavirin, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
DidanosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionFeb 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Bristol-Myers Squibb, ICN Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Japour AJ, Study chairLertora JJ, Study chairCrumpacker C, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000772
- Sponsor's protocol ID
- ACTG 231
- Other IDs
- 11208
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
- ClinicalTrials.gov ID
- NCT00000772
- Acronym / sponsor ID
- ACTG 231
- Conditions
- HIV Infections
- Keywords
- Ribavirin, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Bristol-Myers Squibb, ICN Pharmaceuticals
- Study completion
- Feb 1995 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (22 listed)
- Concurrent rifampin or rifabutin.
- Other anti-HIV drugs and investigational agents.
- Biological response modifiers.
- Ganciclovir or foscarnet.
- Systemic cytotoxic chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ribavirin | Drug | – |
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- BackgroundJapour 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
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Japour AJ study chair
Lertora JJ study chair
Crumpacker C study chair
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ribavirin and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.