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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000844 |
Purpose
To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals.
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Interferon alfa-n3 Drug: Interferon alfa-n1 |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Efficacy Study |
| Official Title: | A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3 |
| Estimated Enrollment: | 560 |
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Patients with the following prior condition are excluded:
Prior Medication:
Excluded:
Contacts and Locations| United States, California | |
| King - Drew Med Ctr | |
| Los Angeles, California, United States, 90059 | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 94063 | |
| United States, Connecticut | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, Delaware | |
| Med Ctr of Delaware / Wilmington Hosp | |
| Wilmington, Delaware, United States, 19801 | |
| United States, District of Columbia | |
| Abundant Life Clinic Foundation | |
| Washington, District of Columbia, United States, 20019 | |
| Howard Univ Hosp | |
| Washington, District of Columbia, United States, 20059 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Univ of Minnesota Hosp | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| New York Med College / Westchester County Med Ctr | |
| Valhalla, New York, United States, 10595 | |
| Dr Barbara Justice | |
| New York, New York, United States, 10031 | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania Med Ctr | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Meharry Med College | |
| Nashville, Tennessee, United States, 37208 | |
| Study Chair: | Alston B | |
| Study Chair: | Standiford H | |
| Study Chair: | Kumi J | |
| Study Chair: | Greaves W |
More Information
| Study ID Numbers: | DATRI 022 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 25, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000844 |
| Health Authority: | United States: Federal Government |
|
Drug Therapy, Combination Adjuvants, Immunologic Administration, Oral |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Interferon-alpha |
|
Interferon-alpha Virus Diseases Interferon Type I, Recombinant Sexually Transmitted Diseases, Viral HIV Infections Interferons |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome AIDS-Related Complex Interferon Alfa-2a Retroviridae Infections Immunologic Deficiency Syndromes |
|
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Infection Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Lentivirus Infections Growth Inhibitors Angiogenesis Modulating Agents |
