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Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia Clinical research trials and Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia. Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia clinical trial. Human subjects often receive the most effective healthcare possible for their Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia  Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia
Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia
For Condition: HIV Infections,Hemophilia A
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if giving azidothymidine (AZT) to HIV-positive patients with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune system. HIV infects and inactivates certain blood cells that are part of the body's immune system. The damage to the body's immune system can result in unusual infections and/or unusual forms of cancer. A large percentage of hemophiliacs are HIV-positive and there is a clear risk for the development of AIDS in these patients. AZT may be effective in lowering HIV levels and boosting the immune system but its side effects are not understood in these patients.
Details: There is a clear risk for development of AIDS in hemophilic patients. AZT administration has been shown to inhibit HIV replication in vitro. Patients taking AZT have experienced fewer opportunistic infections and improvements in measures of immunity. The most common laboratory abnormalities observed with AZT are hematologic. However, the clinical and laboratory toxicity of AZT remains poorly understood in hemophiliacs. Hepatitis and liver dysfunction are more common in this population compared to other groups at risk for HIV infection. Because AZT is largely metabolized in the liver, drug pharmacokinetics needs to be evaluated in this patient population. Both hemophiliacs and non-hemophiliacs take AZT for a period of 12 weeks. The first dose is administered intravenously. AZT is then given orally every 4 hours while awake (5 doses per day). Patients are evaluated by physical examinations and laboratory assessments. These include HIV culture of blood and leukocyte counts, lymphocyte counts, and lymphocyte subsets measured at study entry and every 4 weeks thereafter. Patients are hospitalized for pharmacokinetic studies at study entry and at Weeks 6 and 12. Each of these studies involves both intravenous and oral administration within 48 hours of one another. Blood is sampled at 0, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after each administration and urine is collected every 2 hours for 12 hours.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have a bleeding disorder such as hemophilia A or B, a lack of factor VIII (a blood clotting factor), or severe von Willebrand's disease. - Will be available for follow-up for at least a year. - Are at least 12 years old (consent of parent or guardian required if under 18). - Are willing to use an effective method of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: - Have a life-threatening opportunistic (AIDS-related) infection or AIDS-related symptoms. - Have taken certain drugs within 30 days prior to study entry including chemotherapy and interferon. - Are taking acetaminophen or drugs containing acetaminophen. - Are pregnant or breast-feeding.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
RichardReichman, Study Chair,
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: ACTG 017;
Study Start Date:
Record last reviewed: October 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000705
Other Hiv Infections Studies:
1. A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
2. The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success with Protease Inhibitors
3. Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children
4. A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
5. Effectiveness of Adding Remune to Your Current Anti-HIV Drug Combination
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia
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