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Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients Clinical research trials and Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients. Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients clinical trial. Participants frequently obtain the most expert healthcare available for their Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients  Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Interferon Sciences ,
Synopsis: 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.
Details: The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of the placebo controlled period are concluded successfully.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - 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: Allowed: - 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: Excluded: - Ketoconazole. - Trimethoprim / sulfamethoxazole (TMP/SMX). - Experimental medications. Patients with the following are excluded: - Absolute CD4 count of < 100 or > 350 cells/mm3. - 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.
Total Enrollment: 45
Location and Contact Information:
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: 069A; 90-151ME
Study Start Date:
Record last reviewed: March 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002012
Other Hiv Infections Studies:
1. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
2. A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
3. A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
4. Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
5. A Study of L-735,524 in HIV-Positive Children and Adolescents
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Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
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