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The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections Clinical research trials and The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections clinical trial. Subjects typically recieve the finest healthcare available for their The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections  The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
For Condition: HIV Infections,Hepatitis C
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Schering-Plough
Synopsis: To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy. IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
Details: IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined. Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months. If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy, dose is increased. Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months. All patients will also receive available nucleoside analog therapy ( zidovudine, didanosine, zalcitabine ) at currently accepted doses as clinically appropriate.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Treatment or suppression of opportunistic infections with standard drugs. - Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines. - Clinically indicated antibiotics. - Short courses of steroids (< 21 days) for acute problems not related to hepatitis C. - Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives. Patients must have: - HIV positivity. - Documented hepatitis C virus. - CD4 count <= 200 cells/mm3. - No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C. - Willingness to be followed for the duration of treatment and follow-up period. Prior Medication: Allowed: - Prior AZT, ddI, and ddC. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Hepatitis B (HBsAg positive). - Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160). - Wilson's disease. - alpha-1 antitrypsin deficiency. - Hemochromatosis. - Malignancy requiring systemic chemotherapy. Concurrent Medication: Excluded: - Nonnucleoside analog therapy for HIV. - Biologic response modifiers. - Systemic cytotoxic chemotherapy. - Chronic systemic steroid use. Concurrent Treatment: Excluded: - Radiation therapy other than local irradiation to the skin. Prior Medication: Excluded: - Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration). - Acute therapy for an infection within 2 weeks prior to study entry.
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
GillJC, Study Chair,
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127
United States
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, 17033
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Additional Information:
Study ID Numbers: ACTG 203P;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001035
Other Hiv Infections Studies:
1. Treatment Plan to Decrease Drug Exposure in HIV Infected Adolescents
2. A Study of LXR015-1 in HIV-Infected Patients
3. A Study of HIV Levels During Pregnancy and After Childbirth
4. A Study of Nonoxynol-9 (N-9) and HIV Infection
5. The Safety and Effectiveness of Different Doses of Vitamin C in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
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Other Bronx Clinical Trials
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
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