NCT00002012CompletedNot Applicable
Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
Interferon Sciences1 site in 1 country45 target enrollmentStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
Study Overview
Brief Summary
To conduct a parallel-group, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of an orally administered low dose interferon alfa-n3 as an immunomodulator in the treatment of mild to moderate symptomatic HIV+, AIDS-related complex (ARC) patients.
Detailed Description
The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of the placebo controlled period are concluded successfully.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •Zidovudine (AZT).
- •Patients must have:
- •Diagnosis of AIDS related complex (ARC).
- •Given written informed consent.
- •Been receiving a dose of = or < 600 mg/day of zidovudine (AZT) at least 90 days prior to study entry IF they are currently taking AZT.
- •Prior Medication:
- •Zidovudine (AZT) at a dose = or < 600 mg/day at least 90 days prior to study entry.
Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •History of AIDS-defining condition or evidence of AIDS dementia.
- •Evidence of chronic hepatitis with severe liver dysfunction, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular or psychiatric disorder that would limit the subject's ability to complete the 12 weeks of the study period.
- •Concurrent Medication:
- •Ketoconazole.
- •Trimethoprim / sulfamethoxazole (TMP/SMX).
- •Experimental medications.
- •Patients with the following are excluded:
- •Absolute CD4 count of < 100 or > 350 cells/mm
- •Any disease or disorder listed in Patient Exclusion Co-existing Conditions.
- •Unlikely or unable to comply with the requirements of the protocol.
- •Unwilling or unable to give informed consent.
- •Development of antibodies to interferon during prior interferon therapy that occurred > 3 months prior to study entry.
- •Prior Medication:
- •Excluded within 45 days of study entry:
- •Immunomodulators (e.g., BCG vaccine, isoprinosine).
- •Chemotherapy.
- •Steroids.
- •Excluded within 3 months of study entry:
- •Interferon therapy. Active IV drug abuse.
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant TherapyMajor Depressive DisorderNCT01437657Hoffmann-La Roche319
Completed
Phase 3
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in KoreanAcute MigraineNCT04218162IlDong Pharmaceutical Co Ltd294
Completed
Phase 1
A Study of Aleglitazar in Combination With Aspirin in Healthy VolunteersHealthy VolunteerNCT01188304Hoffmann-La Roche44
Completed
Phase 1
A Study of Aleglitazar in Combination With Ibuprofen in Healthy VolunteersHealthy VolunteerNCT01188317Hoffmann-La Roche44
Completed
Phase 2
A Study of RO4917523 in Pediatric Patients With Fragile X SyndromeFragile X SyndromeNCT01750957Hoffmann-La Roche47