HIV InfectionsPhase 1NCT00002078
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
A Phase 1 study testing Interferon alfa-n3 in people with HIV Infections, run by Purdue Frederick at 2 sites in United States.
Trial summary
To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals. 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
- Not given
- Where
- 2 sitesUnited 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- HIV-1 seropositivity.
- CD4 count > 400/mm3.
- Eligibility for care in the military medical system.
- Prior Medication:
- Allowed:
- Acyclovir.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
- Evidence of AIDS dementia.
- Chronic hepatitis with severe liver dysfunction.
- Active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, or psychiatric disorder that would limit ability to complete the study.
Show all 31Show fewer
- Hemophilia.
- Co-existent disease likely to result in death within the next 2 years.
- Known hypersensitivity to human interferon alpha.
- Known anaphylactic hypersensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin.
- Concurrent Medication:
- Excluded:
- Any other concurrent experimental medications.
- Patients with the following prior conditions are excluded:
- History of AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
- Evidence of chronic hepatitis with severe liver dysfunction.
- Prior Medication:
- Excluded within 5 days prior to study entry:
- Immunosuppressive agents.
- Chemotherapy.
- Steroids.
- Excluded within 45 days prior to study entry:
- BCG vaccine.
- Isoprinosine.
- Other immune modulators.
- Excluded within 3 months prior to study entry:
- Any form of interferon.
- Antiviral therapy.
- Immunoregulatory therapy (other than acyclovir).
- 1. Active drug abuse (narcotic or alcohol abuse documented within the past 6 months).
- Unlikely or unable to comply with the requirements of the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Natl Naval Med Ctr
Bethesda, Maryland, 20889
Walter Reed Army Institute of Research
Washington D.C., District of Columbia, 20307
About this study
To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.
- Conditions
- HIV Infections
- Being tested
- Interferon alfa-n3
- Keywords
- Drug Evaluation, Interferon-alpha
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Purdue Frederick
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Henry M. Jackson Foundation for the Advancement of Military Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002078
- Sponsor's protocol ID
- 082A
- Status last verified
- Nov 1993
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Skillman DR, Wagner K, Malone JL, Decker C, Paparello S, Meltzer MS. Phase 1 study of interferon alfa-N3 in asymptomatic HIV-infected persons. Int Conf AIDS. 1993 Jun 6-11;9(1):468 (abstract no PO-B26-1998)
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
- Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
- ClinicalTrials.gov ID
- NCT00002078
- Acronym / sponsor ID
- 082A
- Conditions
- HIV Infections
- Keywords
- Drug Evaluation, Interferon-alpha
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Purdue FrederickIndustry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Henry M. Jackson Foundation for the Advancement of Military Medicine
- 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 tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 seropositivity.
- CD4 count > 400/mm3.
- Eligibility for care in the military medical system.
- Acyclovir.
Key exclusion criteria (31 listed)
- AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
- Evidence of AIDS dementia.
- Chronic hepatitis with severe liver dysfunction.
- Active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, or psychiatric disorder that would limit ability to complete the study.
- Hemophilia.
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.
- BackgroundSkillman DR, Wagner K, Malone JL, Decker C, Paparello S, Meltzer MS. Phase 1 study of interferon alfa-N3 in asymptomatic HIV-infected persons. Int Conf AIDS. 1993 Jun 6-11;9(1):468 (abstract no PO-B26-1998)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interferon alfa-n3 in people with HIV Infections, run by Purdue Frederick 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 7 inclusion and 31 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 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 NCT00002078, 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 24 Jun 2005.