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Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People Clinical research trials and Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People. Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People clinical trial. Human subjects often get the best healthcare available for their Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People  Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects. The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon (PEG-IFN) alfa-2a in HIV infected people currently on antiretroviral therapy (ART) interruption.
Details: IFN is an immune response enhancer and is produced in the body in response to viral infection. PEG-IFN may have less harmful side effects than non-pegylated IFN. Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment. PEG-IFN alfa-2a has demonstrated potentially useful antiviral properties in HIV treatment; however, due to the high doses that must be administered to maintain viral suppression, toxicity (especially to the blood) is a concern. This study will evaluate the safety, tolerability, and antiretroviral activity of PEG-IFN alfa-2a in HIV infected patients who have received ART in the past but are currently off ART. The study will last 18 weeks. Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks. After Week 12, participants will be followed off-treatment until Week 18. Physical exams will be performed weekly. Blood collection to monitor viral load, PEG-IFN alfa-2a serum levels, and CD4 and CD8 counts will be conducted at selected weeks during the study. Filgrastim will be given to patients who exhibit neutropenic toxicity.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV infected - CD4 count of 300 cells/ml or greater within 30 days of study entry - HIV viral load of 5000 copies/ml or greater within 30 days of study entry - Received antiretroviral therapy previously but have currently interrupted treatment within 12 weeks prior to study entry - Willing to delay re-initiation of antiretroviral medications for the duration of the study - Agree to use acceptable forms of contraception Exclusion Criteria - Previous use of interferon alfa - Known allergy or sensitivity to PEG-IFN alfa-2a or its formulation - Active drug or alcohol abuse that would interfere with the study - Acute therapy for a serious infection within 30 days of study entry - Use of non-protocol-specified immunomodulatory therapy within 60 days of study entry - Active immunization within 30 days of study entry - History of severe psychiatric disease such as major depression, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to psychiatric disease - History of poorly controlled thyroid disease, including history of elevated thyroid stimulating hormone (TSH) levels with elevated antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease - History of clinically significant heart disease that could be worsened by acute anemia - History of severe seizure disorder or current anticonvulsant use - Hepatitis C antibody positive within 60 days prior to study entry - Hepatitis B surface antigen positive within 60 days prior to study entry - Known sensitivity to E. coli derived products, such as filgrastim - Any past evidence of chronic liver disease - Any past or current evidence of immunologically-mediated disease - Evidence of chronic pulmonary disease - Severe eye problems due to diabetes, hypertension, cytomegalovirus infection, or macular degeneration - History of major organ transplantation with an existing functional graft - History or other evidence of severe illness, cancer, or other conditions that would make the patient unsuitable for the study - Hemoglobin abnormalities or any other cause of or tendency for breakdown of red blood cells - Any medical condition that would prevent successful completion of the study - Use of certain medications - Pregnant or breastfeeding
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
DavidAsmuth, Study Chair, Division of Infectious and Immunologic Diseases, University of California, Davis Medical Center
University of California, Davis Medical Center
Sacramento, California, 95814
United States
Nancy Fitch 916-914-6263
UC Davis Medical Center
Sacramento, California, 95814
United States
Nancy Fitch 916-914-6263
Additional Information:
Study ID Numbers: ACTG A5192;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078442
Other Hiv Infections Studies:
1. T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
2. A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
3. Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
4. A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
5. Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
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Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
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