Clinical trial NCT00002078: Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
Official title: Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Drug Evaluation
Interferon-alpha
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
Collaborators: name: Walter Reed Army Institute of Research (WRAIR)
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* CD4 count \> 400/mm3.
* Eligibility for care in the military medical system.

Prior Medication:

Allowed:

* Acyclovir.

Exclusion Criteria

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.
* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Institute of Research
state: District of Columbia
city: Bethesda
country: United States
facility: Natl Naval Med Ctr
state: Maryland
Study officials:
References:
citation: 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)