HIV InfectionsPhase 1NCT00001015
A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems
A Phase 1 study testing Ribavirin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the… 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
- How many people
- 96 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento Jun 1990
- 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:
- Short-course therapy (7 days) with oral acyclovir.
- Short-course therapy (7 days) with ketoconazole.
- Topical medications.
- Aerosolized pentamidine for prophylactic purposes.
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- Concurrent Treatment:
- Allowed:
- Blood transfusions for hemoglobin toxicity.
- Patients must have two positive HIV p24 antigen tests with titers = or > 70 picograms at least 72 hours apart and within 1 month prior to entry, the last of which must be within 2 weeks of starting therapy.
- Prior Medication:
- Allowed:
- Zidovudine (AZT), without cessation of therapy required due to intolerance.
- AZT therapy must be discontinued at least 30 days prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or > 3 liquid stools per day within the past week.
- Concurrent Medication:
- Excluded:
- Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
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- Antineoplastic therapy.
- Other experimental medications.
- Systemic chemoprophylaxis for Pneumocystis carinii pneumonia.
- Chronic (> 7 days) oral acyclovir therapy.
- Concurrent Treatment:
- Excluded:
- Blood transfusions unless they are for = or > grade 3 hemoglobin toxicity.
- Patients with the following are excluded:
- Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or > 3 liquid stools per day within the past week.
- Prior Medication:
- Excluded within 30 days of study entry:
- Antiretroviral agents including zidovudine (AZT).
- Biologic modifiers.
- Systemic corticosteroids.
- Prior Treatment:
- Excluded within 2 months of study entry:
- Blood transfusion except for those who have taken zidovudine (AZT) who may not have received a transfusion within the previous month.
- Active drug or alcohol abuse.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
About this study
Official title: A Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses
To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood.
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).
Read the detailed description
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).
Patients are selected from three patient groups:
- Patients with AIDS, who have not taken zidovudine (AZT) within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance.
- Patients with AIDS related diseases who have not taken AZT within 30 days of entry into the study, and who have not been discontinued from AZT because of intolerance.
- Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy. This is an outpatient study; patients are seen weekly for the first 4 weeks, every other week through week 12, and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study. Patients from each of the three diagnostic groups are enrolled at each dose level. For the first 3 days after entry into the study, all patients receive the lowest dose of RBV every 6 hours. Subsequent dosages increase until the maximum tolerated dose (MTD) is reached. The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage.
Patients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance.
- Conditions
- HIV Infections
- Being tested
- Ribavirin
- Keywords
- Ribavirin, T-Lymphocytes, 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
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 completionJun 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 96 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Crumpacker C, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001015
- Sponsor's protocol ID
- ACTG 034
- Other IDs
- 11010
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Crumpacker C, Pearlstein G, van der Horst C, Valentine F, Spector S, Mills J. A phase one increasing dose trial of oral ribavirin (RBV) in patients with AIDS and ARC. Int Conf AIDS. 1990 Jun 20-23;6(3):203 (abstract no SB468)
Crumpacker C, Cotton D, Pearlstein G, Valentine F, Mills J, Spector S. Ribavirin dose escalating phase 1 trial in patients with AIDS and ARC. Int Conf AIDS. 1989 Jun 4-9;5:336 (abstract no TBP296)
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses
- ClinicalTrials.gov ID
- NCT00001015
- Acronym / sponsor ID
- ACTG 034
- Conditions
- HIV Infections
- Keywords
- Ribavirin, T-Lymphocytes, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jun 1990 (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 determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood.
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).
Detailed description
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).
Patients are selected from three patient groups:
- Patients with AIDS, who have not taken zidovudine (AZT) within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance.
- Patients with AIDS related diseases who have not taken AZT within 30 days of entry into the study, and who have not been discontinued from AZT because of intolerance.
- Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy. This is an outpatient study; patients are seen weekly for the first 4 weeks, every other week through week 12, and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study. Patients from each of the three diagnostic groups are enrolled at each dose level. For the first 3 days after entry into the study, all patients receive the lowest dose of RBV every 6 hours. Subsequent dosages increase until the maximum tolerated dose (MTD) is reached. The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage.
Patients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance.
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 (14 listed)
- Short-course therapy (7 days) with oral acyclovir.
- Short-course therapy (7 days) with ketoconazole.
- Topical medications.
- Aerosolized pentamidine for prophylactic purposes.
- Blood transfusions for hemoglobin toxicity.
Key exclusion criteria (24 listed)
- Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or > 3 liquid stools per day within the past week.
- Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
- Antineoplastic therapy.
- Other experimental medications.
- Systemic chemoprophylaxis for Pneumocystis carinii pneumonia.
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 | – |
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 1 Nov 2021.
- BackgroundCrumpacker C, Pearlstein G, van der Horst C, Valentine F, Spector S, Mills J. A phase one increasing dose trial of oral ribavirin (RBV) in patients with AIDS and ARC. Int Conf AIDS. 1990 Jun 20-23;6(3):203 (abstract no SB468)
- BackgroundCrumpacker C, Cotton D, Pearlstein G, Valentine F, Mills J, Spector S. Ribavirin dose escalating phase 1 trial in patients with AIDS and ARC. Int Conf AIDS. 1989 Jun 4-9;5:336 (abstract no TBP296)
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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.
Crumpacker C study chair
5 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 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 14 inclusion and 24 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 NCT00001015, which also lists 2 linked publications.
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 1 Nov 2021.