Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects
Completed · Not applicable
Conditions studied: HIV Infections
In brief
To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
Key facts
- Study ID
- NCT00002018
- Run by
- Interferon Sciences
- People needed
- 60
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- Didanosine (ddI)
- Patients must have:
- Seropositivity to HIV-1 by ELISA and Western blot.
- At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
- Written informed consent.
- If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.
- Prior Medication:
- Allowed:
- Zidovudine (AZT).
- Didanosine (ddI)
You may not qualify if…
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Major active opportunistic infection requiring active care within 2 weeks of study entry.
- Evidence of chronic hepatitis with severe liver dysfunction:
- albumin < 2 g/dl and SGOT or SGPT > 5 x upper limit of normal prothrombin time > 1.5 x upper limit of normal).
- Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
- Transfusion dependency defined as requiring > 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.
- Concurrent Medication:
- Excluded:
- Experimental medications other than didanosine (ddI).
- Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
- Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).
- Patients with the following are excluded:
- Asymptomatic at study entry.
- Presence of antibodies to interferon due to prior therapy.
- Hospitalization within 2 weeks of study entry.
- Transfusion dependency.
- Unwilling or unable to give informed consent.
- Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
- Unlikely or unable to comply with the requirements of the protocol.
- Prior Medication:
- Excluded within 6 weeks of study entry:
- Interferons.
- Excluded within 45 days of study entry:
- Immunosuppressive agents.
Where it is running
- Mount Sinai Med Ctr — New York, New York, United States
Full record on ClinicalTrials.gov
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