A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects

NCT00215852 | Terminated Phase 2

• 1 other identifier: LDO-101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

To conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of interferon response. Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels.

Conditions

HIV Infections

Keywords

Alferon LDO; Low Dose Oral Interferon; Alfa-n3; Human Leukocyte Derived; HIV; Asymptomatic HIV; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Gene expression analysis

  Days 0, 2, 5, 11, 12 and 16

Secondary Outcomes (1)

• CD4 Level

  Days 0, 11 and 16

Study Arms (3)

1

ACTIVE COMPARATOR

500 IU

Drug: Alferon LDO

2

ACTIVE COMPARATOR

1000 IU

Drug: Alferon LDO

3

ACTIVE COMPARATOR

2000 IU

Drug: Alferon LDO

Interventions

Alferon LDO DRUG

500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• HIV-1 plasma RNA \> 500 copies/ml (Roche Amplicor assay) or similar assay within 45 days of starting oral dosing.
• Karnofsky performance status of 100
• Subjects must be asymptomatic with regard to HIV related clinical symptoms including the following opportunistic infections: Oral candidiasis (thrush), cutaneous herpes simplex, fever, diarrhea, weight loss ≥ 10% of body weight, seborrheic dermatitis, chronic mucocutaneous fungal infections or Kaposi's sarcoma. Subjects with a history of AIDS are not eligible.
• Serum creatinine ≤ 1.5 ULN; serum bilirubin ≤ 2.0 ULN.
• Total WBC ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3.
• Absolute CD4 cell count greater than 400 (based on the average CD4 count from the two pretherapy tests).
• Hemoglobin \> 10.0 g/dl.
• AST \< 4 times upper normal limit.
• ALT \< 4 times upper normal limit.
• Serum Albumin \> 2.0 g/dl.
• Written informed consent.
• Females must either be of non-child bearing potential, or utilize an effective form of contraception and have a negative pregnancy test within 14 days of entry.
• For those subjects who are on antiretroviral therapy, they must have been on a stable dose schedule for at least 90 days prior to study entry and must continue on the same schedule during the treatment phase of this study.

You may not qualify if:

• Pregnant or nursing women, or women not using an effective form of contraception.
• Less than 18 years of age.
• Active IV drug users.
• Absolute CD4 ≤ 400 mm3 (based on the average CD4 counts from the two pretherapy tests).
• Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.
• Receipt of any immunomodulator such as BCG vaccine, isoprinosine, or similar experimental agents within 45 days of study entry.
• Evidence of chronic hepatitis, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurological, or psychiatric disorder that would limit the subject's ability to complete the study period.
• Unlikely or unable to comply with the requirements of the protocol.
• Patients unwilling or unable to give informed consent.
• Patients on any other concurrent experimental medication.
• Concurrent, chronic prophylactic use of any systemic antifungal medication (e.g. ketoconazole, fluconazole, clotrimazole) or of any systemic anti-viral (e.g. acyclovir or ganciclovir) except for antiretroviral therapy.
• Patients using any form of interferon therapy during the 6 weeks prior to study entry. If prior interferon therapy has been received, the subject must not have known development of antibodies to interferon.
• Hospitalized subjects, or those with an active viral infection other than HIV, within 2 weeks of study entry.
• Transfusion dependent subjects (subjects requiring \> 1 unit of packed RBC per month within the 3 months prior to study entry).
• Subjects who are symptomatic of their HIV infection at study entry.

Sponsors & Collaborators

• AIM ImmunoTech Inc.: lead

Study Sites (2)

Drexel University School of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Philadelphia FIGHTS

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• David R Strayer, MD

  AIM ImmunoTech Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 4, 2013

Record last verified: 2013-08

Locations

US (2)