HIV InfectionsPhase 1NCT00000699
A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
A Phase 1 study testing Inosine pranobex and Ribavirin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To determine the safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine (INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV). Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when RBV is given with INPX. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Inosine pranobex and Ribavirin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- It must be possible to culture HIV from peripheral blood lymphocytes on 2 consecutive screenings within 2 months of starting treatment.
- Concurrent Medication:
- Allowed:
- Systemic medications not listed in the Exclusion Concurrent Medications field considered necessary for the patient's medical management and which would not interfere with the study may be used, but such use must be documented.
Who cannot join
- Concurrent Medication:
- Excluded:
- Systemic steroids.
- Cytotoxic immunosuppressive medications.
- Any systemic experimental anti-HIV drug such as dideoxycytidine (ddC), foscarnet, ribavirin, isoprinosine, or zidovudine (AZT).
- Any other medication felt to be immunomodulatory or felt to exhibit significant hepatotoxicity or hematologic or renal toxicity by study investigators.
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- Prior Medication:
- Excluded within 6 weeks of study entry:
- Systemic steroids.
- Cytotoxic immunosuppressive medications.
- Any systemic experimental anti-HIV drug such as dideoxycytidine (ddC), foscarnet, ribavirin, isoprinosine, or zidovudine (AZT).
- Any other medication felt to be immunomodulatory or felt to exhibit significant hepatotoxicity or hematologic or renal toxicity by study investigators.
- Current active infections, known cardiac disease, or prior history of one of the following:
- Gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction.
- Neoplasms:
- Other than locally treated basal or squamous carcinoma.
- Cardiovascular:
- Myocardial infarction, cardiac arrhythmia, cardiomyopathy, or congestive heart failure.
- Past or current history of CDC-defined AIDS including HIV encephalopathy and HIV wasting syndrome. Constitutional symptoms (CDC Group IV-A), neurologic symptoms (CDC Group IV-B), or any prior or current non-AIDS defining secondary infectious disease (CDC Group IV-C2). Grade 1 impairment on 2 or more items in the ACTG Micro Neuro-AIDS Assessment.
- Active drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
To determine the safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine (INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV). Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when RBV is given with INPX. The patients may or may not have generalized lymphadenopathy syndrome (LAS). RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV. The immune system fights infections in the human body, and the HIV attacks T cells that are an important part of the immune system. Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients, but there is no reliable information on the safety and effectiveness of this drug combination in such patients.
Read the detailed description
RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV. The immune system fights infections in the human body, and the HIV attacks T cells that are an important part of the immune system. Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients, but there is no reliable information on the safety and effectiveness of this drug combination in such patients.
All patients take INPX capsules 4 times a day and RBV capsules 2 or 3 times a day. The first group of patients take the dose of RBV shown to be effective in an earlier trial and subsequent groups take higher doses until toxic effects occur. The planned treatment period is 3 months, but further treatment may be allowed for patients showing improvement. Blood samples are taken from an arm vein and used to evaluate possible changes in the patient's immune system, any toxic effects that might be detected in the blood and possible changes in the presence of HIV in the blood.
- Conditions
- HIV Infections
- Being tested
- Inosine pranobex, Ribavirin
- Keywords
- Ribavirin, Inosine Pranobex, Dose-Response Relationship, Drug, Drug Evaluation, Drug Therapy, Combination, 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.
Inosine pranobexDrug
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.
- 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
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Schulof RS, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000699
- Sponsor's protocol ID
- NS 403
- Status last verified
- Apr 2003
- First submitted
- 2 Nov 1999
- Last updated
- 26 Aug 2008
- Results posted
- No
Publications
Schulof R, Simon G, Parenti D, Sztein M, Meyer W, Paxton H. Phase I/II trial of ribavirin + isoprinosine in asymptomatic HIV viremic gay men. Int Conf AIDS. 1989 Jun 4-9;5:212 (abstract no ThBO2)
Schulof RS, Parenti DM, Simon GL, Paxton H, Meyer WA 3rd, Schlesselman SB, Courtless J, LeLacheur S, Sztein MB. Clinical, virologic, and immunologic effects of combination therapy with ribavirin and isoprinosine in HIV-infected homosexual men. J Acquir Immune Defic Syndr (1988). 1990;3(5):485-92.
PubMed 1691287
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
- ClinicalTrials.gov ID
- NCT00000699
- Acronym / sponsor ID
- NS 403
- Conditions
- HIV Infections
- Keywords
- Ribavirin, Inosine Pranobex, Dose-Response Relationship, Drug, Drug Evaluation, Drug Therapy, Combination, AIDS-Related Complex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine (INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV). Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when RBV is given with INPX. The patients may or may not have generalized lymphadenopathy syndrome (LAS). RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV. The immune system fights infections in the human body, and the HIV attacks T cells that are an important part of the immune system. Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients, but there is no reliable information on the safety and effectiveness of this drug combination in such patients.
Detailed description
RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV. The immune system fights infections in the human body, and the HIV attacks T cells that are an important part of the immune system. Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients, but there is no reliable information on the safety and effectiveness of this drug combination in such patients.
All patients take INPX capsules 4 times a day and RBV capsules 2 or 3 times a day. The first group of patients take the dose of RBV shown to be effective in an earlier trial and subsequent groups take higher doses until toxic effects occur. The planned treatment period is 3 months, but further treatment may be allowed for patients showing improvement. Blood samples are taken from an arm vein and used to evaluate possible changes in the patient's immune system, any toxic effects that might be detected in the blood and possible changes in the presence of HIV in the blood.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- It must be possible to culture HIV from peripheral blood lymphocytes on 2 consecutive screenings within 2 months of starting treatment.
- Systemic medications not listed in the Exclusion Concurrent Medications field considered necessary for the patient's medical management and which would not interfere with the study may be used, but such use must be documented.
Key exclusion criteria (20 listed)
- Systemic steroids.
- Cytotoxic immunosuppressive medications.
- Any systemic experimental anti-HIV drug such as dideoxycytidine (ddC), foscarnet, ribavirin, isoprinosine, or zidovudine (AZT).
- Any other medication felt to be immunomodulatory or felt to exhibit significant hepatotoxicity or hematologic or renal toxicity by study investigators.
- Systemic steroids.
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 |
|---|---|---|
| Inosine pranobex | Drug | – |
| 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 26 Aug 2008.
- BackgroundSchulof R, Simon G, Parenti D, Sztein M, Meyer W, Paxton H. Phase I/II trial of ribavirin + isoprinosine in asymptomatic HIV viremic gay men. Int Conf AIDS. 1989 Jun 4-9;5:212 (abstract no ThBO2)
- Background: PubMed 1691287Schulof RS, Parenti DM, Simon GL, Paxton H, Meyer WA 3rd, Schlesselman SB, Courtless J, LeLacheur S, Sztein MB. Clinical, virologic, and immunologic effects of combination therapy with ribavirin and isoprinosine in HIV-infected homosexual men. J Acquir Immune Defic Syndr (1988). 1990;3(5):485-92.
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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.
Schulof RS study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inosine pranobex and Ribavirin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 4 inclusion and 20 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 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 NCT00000699, 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 26 Aug 2008.