Status:
TERMINATED
A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects
Lead Sponsor:
AIM ImmunoTech Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. T...
Detailed Description
This study will be an open-label, randomized outpatient study in HIV infected subjects using a range of doses of Alferon LDO. The first nine (9) patients enrolled will not be randomized. Instead, the ...
Eligibility Criteria
Inclusion
- 18 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00215852
Start Date
July 1 2005
End Date
April 1 2009
Last Update
September 4 2013
Active Locations (2)
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1
Drexel University School of Medicine
Philadelphia, Pennsylvania, United States, 19102
2
Philadelphia FIGHTS
Philadelphia, Pennsylvania, United States, 19107