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

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIM ImmunoTech Inc.; Hemispherx Biopharma
• Treatments: Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

1. 18 years of age or older.

2. HIV-1 plasma RNA > 500 copies/ml (Roche Amplicor assay) or similar assay within 45 days of starting oral dosing.

3. Karnofsky performance status of 100

4. 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.

5. Serum creatinine ≤ 1.5 ULN; serum bilirubin ≤ 2.0 ULN.

6. Total WBC ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3.

7. Absolute CD4 cell count greater than 400 (based on the average CD4 count from the two pretherapy tests).

8. Hemoglobin > 10.0 g/dl.

9. AST < 4 times upper normal limit.

10. ALT < 4 times upper normal limit.

11. Serum Albumin > 2.0 g/dl.

12. Written informed consent.

13. 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.

14. 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.

Exclusion Criteria:

1. Pregnant or nursing women, or women not using an effective form of contraception.

2. Less than 18 years of age.

3. Active IV drug users.

4. Absolute CD4 ≤ 400 mm3 (based on the average CD4 counts from the two pretherapy tests).

5. Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.

6. Receipt of any immunomodulator such as BCG vaccine, isoprinosine, or similar experimental agents within 45 days of study entry.

7. 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.

8. Unlikely or unable to comply with the requirements of the protocol.

9. Patients unwilling or unable to give informed consent.

10. Patients on any other concurrent experimental medication.

11. 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.

12. 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.

13. Hospitalized subjects, or those with an active viral infection other than HIV, within 2 weeks of study entry.

14. Transfusion dependent subjects (subjects requiring > 1 unit of packed RBC per month within the 3 months prior to study entry).

15. Subjects who are symptomatic of their HIV infection at study entry.