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
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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: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | June 2002 |
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:
- Symptomatic HIV infection.
- CD4 count 50 - 350 cells/mm3.
Prior Medication:
Allowed:
- Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry).
- Maintenance therapy for a chronic condition.
Exclusion Criteria
Patients with the following prior condition are excluded:
- Change in antiretroviral therapy within past 6 weeks.
Prior Medication:
Excluded:
- Oral IFN-alpha or other immune-based therapy within the past month.
- Therapy for any acute disease within the past week.
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 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| Dr Barbara Justice | |
| New York, New York, United States, 10031 | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| New York Med College / Westchester County Med Ctr | |
| Valhalla, New York, United States, 10595 | |
| 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
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000844 History of Changes |
| Other Study ID Numbers: | DATRI 022, 11727 |
| Study First Received: | November 2, 1999 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Drug Therapy, Combination Adjuvants, Immunologic Administration, Oral |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Interferon-alpha |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Adjuvants, Immunologic Interferon-alpha |
Interferon Alfa-2a Interferons Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013