HIV InfectionsNCT00002298
The Safety and Effectiveness of Ribavirin in the Early Stages of HIV-Infection
A study testing Ribavirin in people with HIV Infections, run by ICN Pharmaceuticals.
Trial summary
The objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ribavirin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Acyclovir.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- CDC classification group IV A (ARC).
- CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years). Positive plasma p24 antigen.
- Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
- Splenectomy.
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- Concurrent Medication:
- Excluded:
- Isoprinosine.
- Patients with the following are excluded:
- Failure to give informed consent.
- CDC classification group IV A (ARC).
- CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years).
- Positive plasma p24 antigen.
- Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
- Splenectomy.
- Prior Medication:
- Excluded within 4 weeks of start of screening tests:
- Zidovudine.
- Other drug with scientifically accepted anti-HIV properties.
- Scientifically accepted immunostimulant treatment.
- Immunosuppressant.
- Myelosuppressant or other known toxic drugs.
- HIV infection group II (CDC), asymptomatic HIV infection.
- HIV antibody positive by Western blot with antibodies to p24 band and GP160 band and/or GP41. Two positive tests during screening will be required. CDC HIV infection group II, asymptomatic HIV infection, as defined in Appendix A, or CDC HIV infection group III, persistent generalized lymphadenopathy (PGL, formerly LAS).
- OKT4+ lymphocyte count greater than 300 cells/mm3 and less than 600 cells/mm3. The counts will be determined on three separate evaluations separated by at least 7 days between evaluations. These three counts will be averaged and for inclusion in the study the mean of the OKT4+ lymphocyte count must be greater than 200 cells/mm3 and less than 600 cells/mm3. Conclusion of screening tests:
- Within 42 days of starting them. Patients must be entered into the study within 14 days of screening completion. Ability to participate as outpatient:
- Ambulatory, competent to sign informed consent, and able to cooperate with the treatment plan and evaluation schedule. Informed consent:
- Must be signed before randomization to treatment. Physical activity evaluation with Karnofsky score greater than or equal to 90.
About this study
Official title: Long-Term Efficacy and Tolerance of Oral Ribavirin Compared to Placebo as a Preventative in Early Stages of Human Immunodeficiency Virus Infection - United States
The objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV disease as defined by CDC classification, and whether the dosage regimen is safe and tolerable in these subjects.
- Conditions
- HIV Infections
- Being tested
- Ribavirin
- Keywords
- Ribavirin, AIDS-Related Complex
- Medical subject headings
- HIV Infections, 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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- ICN Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002298
- Sponsor's protocol ID
- 013A
- Status last verified
- Mar 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Efficacy and Tolerance of Oral Ribavirin Compared to Placebo as a Preventative in Early Stages of Human Immunodeficiency Virus Infection - United States
- ClinicalTrials.gov ID
- NCT00002298
- Acronym / sponsor ID
- 013A
- Conditions
- HIV Infections
- Keywords
- Ribavirin, AIDS-Related Complex
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- ICN PharmaceuticalsIndustry (pharma, biotech, devices)
- 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.
The objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV disease as defined by CDC classification, and whether the dosage regimen is safe and tolerable in these subjects.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Acyclovir.
Key exclusion criteria (29 listed)
- CDC classification group IV A (ARC).
- CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years). Positive plasma p24 antigen.
- Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
- Splenectomy.
- Isoprinosine.
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ribavirin in people with HIV Infections, run by ICN Pharmaceuticals.
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 3 inclusion and 29 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: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
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 24 Jun 2005.