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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000713 |
To determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will be studied.
Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Ampligen |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Pharmacodynamics Study |
Official Title: | A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects |
Estimated Enrollment: | 40 |
Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
Individuals entered in the study are given ampligen by intravenous infusion once during the first week of the trial and twice a week during the following 8 weeks. The dose each individual receives is determined by the responses of earlier individuals. Each is followed for 12 weeks after the last dose of ampligen is given. Each individual maintains a daily diary listing any symptoms or problems that occur, such as headache, nausea, or change in appetite. Other anti-HIV drugs cannot be taken during the trial, and aspirin or acetaminophen should not be taken for more than 2 hours without consulting the research staff. Blood is drawn at intervals during the trial and follow-up and used to determine the effect of ampligen on the HIV and the immune system as well as to monitor any toxicity and side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 14 days of study entry:
Concurrent neoplasms other than basal cell carcinoma of the skin.
Active drug or alcohol abuse.
Study ID Numbers: | ACTG 038 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000713 |
Health Authority: | United States: Federal Government |
Polyribonucleotides HIV Seropositivity Dose-Response Relationship, Drug Drug Evaluation |
Acquired Immunodeficiency Syndrome ampligen AIDS-Related Complex Antiviral Agents |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes Ampligen |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses |
Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |