HIV InfectionsNCT00002018
Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects
A study testing Interferon alfa-n3 in people with HIV Infections, run by Interferon Sciences at 1 site in United States.
Trial summary
To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects. 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?
- Interferon alfa-n3
- How many people
- 60 participants
- Where
- 1 siteUnited States
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- Didanosine (ddI)
- Patients must have:
- Seropositivity to HIV-1 by ELISA and Western blot.
Show all 13Show fewer
- At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
- Written informed consent.
- If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.
- Prior Medication:
- Allowed:
- Zidovudine (AZT).
- Didanosine (ddI)
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Major active opportunistic infection requiring active care within 2 weeks of study entry.
- Evidence of chronic hepatitis with severe liver dysfunction:
- albumin < 2 g/dl and SGOT or SGPT > 5 x upper limit of normal prothrombin time > 1.5 x upper limit of normal).
- Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
Show all 34Show fewer
- Transfusion dependency defined as requiring > 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.
- Concurrent Medication:
- Excluded:
- Experimental medications other than didanosine (ddI).
- Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
- Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).
- Patients with the following are excluded:
- Asymptomatic at study entry.
- Presence of antibodies to interferon due to prior therapy.
- Hospitalization within 2 weeks of study entry.
- Transfusion dependency.
- Unwilling or unable to give informed consent.
- Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
- Unlikely or unable to comply with the requirements of the protocol.
- Prior Medication:
- Excluded within 6 weeks of study entry:
- Interferons.
- Excluded within 45 days of study entry:
- Immunosuppressive agents.
- Chemotherapy.
- Steroids.
- Immunomodulators.
- Isoprinosine.
- BCG vaccine.
- Prior Treatment:
- Excluded within 2 weeks of study entry:
- Hospitalization.
- Active intravenous (IV) drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
- Conditions
- HIV Infections
- Being tested
- Interferon alfa-n3
- Keywords
- Interferon Type I
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon alfa-n3Drug
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
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Interferon Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002018
- Sponsor's protocol ID
- 069B
- Other IDs
- 90-355ME
- Status last verified
- Mar 1993
- 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
- Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects
- ClinicalTrials.gov ID
- NCT00002018
- Acronym / sponsor ID
- 069B
- Conditions
- HIV Infections
- Keywords
- Interferon Type I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Interferon SciencesIndustry (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.
To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Zidovudine (AZT).
- Didanosine (ddI)
- Seropositivity to HIV-1 by ELISA and Western blot.
- At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
- Written informed consent.
Key exclusion criteria (34 listed)
- Major active opportunistic infection requiring active care within 2 weeks of study entry.
- Evidence of chronic hepatitis with severe liver dysfunction:
- albumin < 2 g/dl and SGOT or SGPT > 5 x upper limit of normal prothrombin time > 1.5 x upper limit of normal).
- Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
- Transfusion dependency defined as requiring > 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.
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 |
|---|---|---|
| Interferon alfa-n3 | 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 24 Jun 2005.
Related trials for HIV Infections
Recruiting
A Chatbot to Reduce Chemsex and HIV-related Risk Behaviors Among Men Who Have Sex With Men
Behavior
Not yet recruiting
VR Mindfulness for People With HIV and Substance Use
HIV, Substance Use (Drugs, Alcohol)
Not yet recruiting
Adapting the "Do More, Feel Better" Intervention for Older People Living With HIV
Depression, HIV
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
Recruiting
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
HIV1 Infection, HIV 2 Infection
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferon alfa-n3 in people with HIV Infections, run by Interferon Sciences 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 13 inclusion and 34 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 24 Jun 2005. 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.
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?
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.